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Prescription Drugs

💊 Drugs • 11,927 recalls

ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), 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 →

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), 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 →

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08

MACLEODS PHARMA USA

Class I - Dangerous

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Jan 5, 2023 Prescription Drugs Nationwide View Details →

Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

Ascend Laboratories

Class I - Dangerous

Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.

Dec 28, 2022 Prescription Drugs View Details →

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12

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, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10

Lannett Company

Class I - Dangerous

Failed Impurity/Degradation Specifications

Nov 9, 2022 Prescription Drugs Nationwide View Details →

QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Class I - Dangerous

Lack of Assurance of Sterility

Dec 30, 2022 Prescription Drugs Nationwide View Details →

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Class I - Dangerous

Lack of Assurance of Sterility

Dec 30, 2022 Prescription Drugs Nationwide View Details →

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Class I - Dangerous

Lack of Assurance of Sterility

Dec 30, 2022 Prescription Drugs Nationwide View Details →

Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Class I - Dangerous

Lack of Assurance of Sterility

Dec 30, 2022 Prescription Drugs Nationwide View Details →

Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.

RemedyRepack

Class I - Dangerous

Failed Impurities/Degradation specifications

Dec 20, 2022 Prescription Drugs View Details →

Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05

Direct Rx

Class I - Dangerous

cGMP deviation: discontinue of stability support for product.

Nov 2, 2022 Prescription Drugs View Details →

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Class I - Dangerous

Lack of Assurance of Sterility

Dec 30, 2022 Prescription Drugs Nationwide View Details →

BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Northern VA Compounders PLLC

Class I - Dangerous

Lack of Assurance of Sterility

Dec 30, 2022 Prescription Drugs Nationwide View Details →

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