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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 2881–2900 of 17,723 recalls

Class IITerminated

EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IICompleted

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

AVKARE LLC

Failed impurities/degradation specifications: Out of specification for unknown impurities.

December 22, 2022 · DrugView details →

Class IITerminated

MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IITerminated

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

Pharmacy Innovations

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

December 22, 2022 · DrugView details →

Class IIITerminated

Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4

Apotex Corp.

Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.

December 21, 2022 · DrugView details →

Class IITerminated

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 Inc.

Failed Impurities/Degradation specifications

December 20, 2022 · DrugView details →

Class IITerminated

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 LLC

Failed Impurities/Degradations Specifications

December 20, 2022 · DrugView details →

Class ITerminated

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130

Spectrum Laboratory Products, Inc.

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

December 19, 2022 · DrugView details →

Class ITerminated

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.

Spectrum Laboratory Products, Inc.

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

December 19, 2022 · DrugView details →

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