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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 261–280 of 1,000 recalls

Class IIITerminated

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

February 19, 2021 · DrugView details →

Class IIITerminated

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05

Edge Pharma, LLC

Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions

February 17, 2021 · DrugView details →

Class IIITerminated

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurity/Degradation Specifications

February 5, 2021 · DrugView details →

Class IIITerminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

February 2, 2021 · DrugView details →

Class IIITerminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

February 2, 2021 · DrugView details →

Class IIITerminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

February 2, 2021 · DrugView details →

Class IIITerminated

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Failed Dissolution Specifications

January 29, 2021 · DrugView details →

Class IIITerminated

Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)

Accord Healthcare, Inc.

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

January 28, 2021 · DrugView details →

Class IIITerminated

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

January 21, 2021 · DrugView details →

Class IIITerminated

Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50

Calvin Scott & Company, Inc.

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

January 15, 2021 · DrugView details →

Class IIITerminated

Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40

SUN PHARMACEUTICAL INDUSTRIES INC

Incorrect Labeling: Incorrect lot number on secondary packaging

January 11, 2021 · DrugView details →

Class IIITerminated

Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30

Bausch Health Companies, Inc.

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

January 7, 2021 · DrugView details →

Class IIITerminated

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

Bausch Health Companies, Inc.

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

January 7, 2021 · DrugView details →

Class IIITerminated

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

Genus Lifesciences Inc.

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

December 23, 2020 · DrugView details →

Class IIITerminated

NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816

Strides Pharma Inc.

Failed Moisture Limits

December 22, 2020 · DrugView details →

Class IIITerminated

Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01

Edge Pharma, LLC

Labeling: Incorrect or Missing Lot and/or Exp Date

December 22, 2020 · DrugView details →

Class IIITerminated

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

KVK-Tech, Inc.

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

December 18, 2020 · DrugView details →

Class IIITerminated

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

SCA Pharmaceuticals

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

December 17, 2020 · DrugView details →

Class IIITerminated

Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

US Compounding Inc

Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.

December 16, 2020 · DrugView details →

Class IIITerminated

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

US Compounding Inc

Labelling: Missing label.

November 25, 2020 · DrugView details →

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