Home / Recalls / AVKARE Inc. / D-0167-2021

D-0167-2021 Class II Terminated

Recalled by AVKARE Inc. — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
December 23, 2020
Initiation Date
December 7, 2020
Termination Date
October 16, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38715 bottles

Product Description

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

Reason for Recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Distribution Pattern

Nationwide within the U.S.

Code Information

Lot: 36884 Exp. 03/2022

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-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-0529-2025 Class III — Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av (June 26, 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)