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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 3821–3840 of 17,755 recalls

Class IITerminated

Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .

Pfizer Inc.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

March 21, 2022 · DrugView details →
Class IITerminated

The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714.

Revive Personal Products Company

Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC

March 21, 2022 · DrugView details →
Class IITerminated

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23.

Pfizer Inc.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

March 21, 2022 · DrugView details →
Class IITerminated

quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1

Pfizer Inc.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

March 21, 2022 · DrugView details →
Class IITerminated

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.

Pfizer Inc.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

March 21, 2022 · DrugView details →
Class IITerminated

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23.

Pfizer Inc.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

March 21, 2022 · DrugView details →
Class IITerminated

Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23

Pfizer Inc.

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

March 21, 2022 · DrugView details →
Class IIITerminated

NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40

Advanced Accelerator Applications USA, Inc.

Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

March 18, 2022 · DrugView details →
Class IITerminated

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.

Aurolife Pharma, LLC

Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.

March 17, 2022 · DrugView details →
Class IIITerminated

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

March 16, 2022 · DrugView details →
Class IIOngoing

Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.

Golden State Medical Supply Inc.

CGMP Deviations

March 16, 2022 · DrugView details →
Class IIOngoing

Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Golden State Medical Supply Inc.

CGMP Deviations

March 16, 2022 · DrugView details →
Class IIOngoing

Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Golden State Medical Supply Inc.

CGMP Deviations

March 16, 2022 · DrugView details →
Class IIOngoing

Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

Golden State Medical Supply Inc.

CGMP Deviations

March 16, 2022 · DrugView details →
Class IITerminated

Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →
Class IITerminated

Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →
Class IITerminated

Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →
Class IITerminated

Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →
Class IITerminated

Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →
Class IITerminated

Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

March 15, 2022 · DrugView details →
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