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Prescription Drugs

💊 Drugs • 11,927 recalls

GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

Class I - Dangerous

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Dec 22, 2022 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

Akorn

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.

Akorn

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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05

Accord Healthcare

Class I - Dangerous

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

Nov 29, 2022 Prescription 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

Akorn

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.

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Fresenius Kabi USA

Class I - Dangerous

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Nov 22, 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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10

Lannett Company

Class I - Dangerous

Failed Impurity/Degradation Specifications

Nov 9, 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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription 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

Akorn

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

Akorn

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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)

Amerisource Health Services

Class I - Dangerous

Failed Impurities/Degradations Specifications

Dec 20, 2022 Prescription Drugs Nationwide View Details →

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.

Intersect ENT

Class I - Dangerous

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Jan 4, 2023 Prescription Drugs Nationwide View Details →

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

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