💊

Prescription Drugs

💊 Drugs • 12,141 recalls

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Jan 22, 2025 Prescription Drugs Nationwide View Details →

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

The Harvard Drug Group LLC

Class I - Dangerous

Failed Dissolution Specifications.

Jan 30, 2025 Prescription Drugs Nationwide View Details →

Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Jan 10, 2025 Prescription Drugs Nationwide View Details →

HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10

SKY PACKAGING

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jan 24, 2025 Prescription Drugs Nationwide View Details →

HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10

SKY PACKAGING

Class I - Dangerous

Failed Impurities/Degradation Specifications

Jan 24, 2025 Prescription Drugs Nationwide View Details →

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

FDC Limited

Class I - Dangerous

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Jan 23, 2025 Prescription Drugs View Details →

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

The Harvard Drug Group LLC

Class I - Dangerous

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Jan 13, 2025 Prescription Drugs Nationwide View Details →

Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.

Astellas Pharma US

Class I - Dangerous

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Dec 23, 2024 Prescription Drugs Nationwide View Details →

Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01

McKesson

Class I - Dangerous

cGMP Deviations: Product intended for quarantine was inadvertently distributed.

Jan 17, 2025 Prescription Drugs Nationwide View Details →

Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.

Astellas Pharma US

Class I - Dangerous

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Dec 23, 2024 Prescription Drugs Nationwide View Details →

FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

SHOPPERS- PLAZA

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

Dec 16, 2024 Prescription Drugs Nationwide View Details →

Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.

Appco Pharma

Class I - Dangerous

Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

Jan 16, 2025 Prescription Drugs Nationwide View Details →

glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11

Amerisource Health Services

Class I - Dangerous

Failed Dissolution Specifications:

Dec 17, 2024 Prescription Drugs Nationwide View Details →

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

Akron Pharma

Class I - Dangerous

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Dec 12, 2024 Prescription Drugs Nationwide View Details →

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11

Amerisource Health Services

Class I - Dangerous

Presence of Foreign Tablets/Capsules

Jan 7, 2025 Prescription Drugs Nationwide View Details →

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

Akron Pharma

Class I - Dangerous

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Dec 12, 2024 Prescription Drugs Nationwide View Details →

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

Akron Pharma

Class I - Dangerous

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Dec 12, 2024 Prescription Drugs Nationwide View Details →

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

Akron Pharma

Class I - Dangerous

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Dec 12, 2024 Prescription Drugs Nationwide View Details →

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

Viatris

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Dec 23, 2024 Prescription Drugs Nationwide View Details →

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

Akron Pharma

Class I - Dangerous

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

Dec 12, 2024 Prescription Drugs Nationwide View Details →

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