Home / Recalls / AvKARE / D-0529-2025

D-0529-2025 Class III Ongoing

Recalled by AvKARE — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
July 9, 2025
Initiation Date
June 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,573 bottles

Product Description

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

Reason for Recall

Failed Impurity/Degradation Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026

Other recalls by AvKARE

  • 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-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)
  • D-0224-2025 Class II — Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufa (January 21, 2025)