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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 9781–9800 of 17,793 recalls

Class IITerminated

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

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Midazolam 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 →

Terminated

Ketamine HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

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

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Lidocaine HCl 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 5% Dextrose in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Meperidine 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

Methadone HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Midazolam HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

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

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

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

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IITerminated

Ropivacaine HCl Injection in all strengths, all doses, and all packaging.

Pharmedium Services, LLC

Lack of sterility assurance.

December 27, 2017 · DrugView details →

Class IIITerminated

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10

Hetero Labs, Ltd. - Unit III

Presence of foreign substance: metallic razor blade was found in one bottle.

December 22, 2017 · DrugView details →

Class IITerminated

Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30

Hetero Labs Limited Unit V

Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.

December 22, 2017 · DrugView details →

Class IIITerminated

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3

Taro Pharmaceuticals U.S.A., Inc.

Failed Content Uniformity Specifications

December 21, 2017 · DrugView details →

Class ITerminated

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

AuroMedics Pharma LLC

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

December 20, 2017 · DrugView details →

Class IITerminated

Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0

Odan Laboratories Ltd

Failed Stability Specifications:stability failure at 12 months, long term RT conditions.

December 20, 2017 · DrugView details →

Class IITerminated

DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.

Fresenius Medical Care Renal Therapies Group, LLC

Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.

December 20, 2017 · DrugView details →

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