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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 3441–3460 of 17,723 recalls

Class IITerminated

Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IITerminated

Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IITerminated

Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IITerminated

Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IITerminated

Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C, 14X, 15X, 16X, 20X, 288X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IITerminated

Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IITerminated

Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411

Washington Homeopathic Products, Inc.

cGMP deviations

May 13, 2022 · DrugView details →
Class IIOngoing

Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.

A.P. Nonweiler

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

May 11, 2022 · DrugView details →
Class IITerminated

Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Direct Rx

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

May 11, 2022 · DrugView details →
Class ITerminated

Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

Teva Pharmaceuticals USA Inc

Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.

May 11, 2022 · DrugView details →
Class IITerminated

Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Direct Rx

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

May 11, 2022 · DrugView details →
Class IITerminated

Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Direct Rx

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

May 11, 2022 · DrugView details →
Class IIITerminated

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →
Class IIOngoing

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668

AMS Packaging Inc

Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

May 10, 2022 · DrugView details →
Class IIITerminated

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →
Class IIITerminated

Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →
Class IIITerminated

Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.

Novartis Pharmaceuticals Corporation

Failed Impurities/Degradation Specifications.

May 10, 2022 · DrugView details →
Class IICompleted

Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0101-30

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
Class IICompleted

T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

May 9, 2022 · DrugView details →
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