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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2901–2920 of 17,723 recalls

Class IIOngoing

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

December 16, 2022 · DrugView details →
Class IITerminated

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01

Hikma Pharmaceuticals USA Inc.

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

December 16, 2022 · DrugView details →
Class IITerminated

Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976

Frenda Corporation

cGMP Deviations

December 15, 2022 · DrugView details →
Class IITerminated

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.

Atlantic Management Resources Ltd.

cGMP Deviations

December 12, 2022 · DrugView details →
Class IITerminated

Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

Atlantic Management Resources Ltd.

cGMP Deviations

December 12, 2022 · DrugView details →
Class IITerminated

Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.

Atlantic Management Resources Ltd.

cGMP Deviations

December 12, 2022 · DrugView details →
Class IITerminated

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

December 12, 2022 · DrugView details →
Class IITerminated

Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.

Atlantic Management Resources Ltd.

cGMP Deviations

December 12, 2022 · DrugView details →
Class IICompleted

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062

NCH Life Sciences LLC

CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.

December 9, 2022 · DrugView details →
Class IITerminated

Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.

McGuff Compounding Pharmacy Services, Inc.

Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

December 8, 2022 · DrugView details →
Class IITerminated

Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.

McGuff Compounding Pharmacy Services, Inc.

Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

December 8, 2022 · DrugView details →
Class IITerminated

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

Lupin Pharmaceuticals Inc.

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

December 7, 2022 · DrugView details →
Class IITerminated

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

Lupin Pharmaceuticals Inc.

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

December 7, 2022 · DrugView details →
Class IIITerminated

Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26

Camber Pharmaceuticals, Inc

Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

December 6, 2022 · DrugView details →
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