Home / Recalls / AVKARE Inc. / D-1131-2018

D-1131-2018 Class II Terminated

Recalled by AVKARE Inc. — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
September 5, 2018
Initiation Date
August 14, 2018
Termination Date
May 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
728 cartons (36,400 tablets)

Product Description

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

U.S. Nationwide

Code Information

Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019

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  • D-0460-2025 Class II — Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Ma (May 13, 2025)
  • D-0461-2025 Class II — Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton (May 9, 2025)
  • D-0229-2025 Class II — Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pul (February 4, 2025)