Home / Recalls / AVKARE Inc. / D-0165-2020

D-0165-2020 Class II Terminated

Recalled by AVKARE Inc. — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
November 6, 2019
Initiation Date
October 17, 2019
Termination Date
October 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1351 bottles

Product Description

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Reason for Recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Distribution Pattern

CO, MO

Code Information

Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020

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)