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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 9741–9760 of 17,793 recalls

Class IITerminated

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30

Hetero Labs, Ltd. - Unit III

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

January 10, 2018 · DrugView details →

Class IITerminated

Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.

Marksans Pharma Inc.

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

January 9, 2018 · Drug

View details →

Class IITerminated

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.

Marksans Pharma Inc.

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

January 9, 2018 · DrugView details →

Class IITerminated

Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.

Marksans Pharma Inc.

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

January 9, 2018 · DrugView details →

Class IITerminated

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.

Marksans Pharma Inc.

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

January 9, 2018 · DrugView details →

Class IITerminated

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.

Marksans Pharma Inc.

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

January 9, 2018 · DrugView details →

Class IITerminated

Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.

Marksans Pharma Inc.

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

January 9, 2018 · DrugView details →

Class ITerminated

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

Advanced Pharma Inc.

Subpotent

January 5, 2018 · DrugView details →

Class ITerminated

Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16

International Laboratories, LLC

LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.

January 4, 2018 · DrugView details →

Class IITerminated

Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.

AVKARE Inc.

Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.

January 3, 2018 · DrugView details →

Class ITerminated

Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20

Aurobindo Pharma Ltd.

Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

January 2, 2018 · DrugView details →

Class IITerminated

Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307.

DLC Laboratories, Inc

Microbial Contamination of Non-Sterile Products.

December 28, 2017 · DrugView details →

Class IITerminated

Glycopyrrolate in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Fentanyl Citrate Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Labetalol HCl in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

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