Home / Recalls / AvKARE / D-0444-2024

D-0444-2024 Class I Terminated

Recalled by AvKARE — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
April 24, 2024
Initiation Date
March 28, 2024
Termination Date
August 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
153 cartons

Product Description

Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.

Reason for Recall

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

Distribution Pattern

US Nationwide.

Code Information

Lot: AW0221A Exp. 08/30/2025

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-0643-2025 Class II — chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose c (August 25, 2025)
  • D-0644-2025 Class II — chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose (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)