Akorn

192 recalls •

💊 Drugs

• Categories: Prescription Drugs, Other Drugs, Compounded Drugs

Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Compounded Drugs Nationwide View Details →

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02

Class I - Dangerous

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Jan 30, 2023 Prescription Drugs Nationwide View Details →

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Other Drugs Nationwide View Details →

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Other Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Other Drugs Nationwide View Details →