Home / Recalls / AVKARE Inc. / D-1133-2018

D-1133-2018 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
1496 cartons (44,880 tablets)

Product Description

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 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: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019

Other recalls by AVKARE Inc.

  • D-0341-2026 Class II — Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, (February 13, 2026)
  • D-0292-2026 Class II — Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per car (December 31, 2025)
  • D-0007-2026 Class II — Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.02 (September 2, 2025)
  • D-0644-2025 Class II — chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose (August 25, 2025)
  • D-0643-2025 Class II — chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose c (August 25, 2025)
  • D-0528-2025 Class III — Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av (June 26, 2025)
  • D-0529-2025 Class III — Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av (June 26, 2025)
  • 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)