Avkare: Amitriptyline Hydrochloride, Tablets, Usp, 10 Mg, 5 X 10 Unit Dose Cards In Paper Cartons
- Recalling firm
- AvKARE
- Product
- Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for AvKARE, Pulaski, TN 38478, NDC 50268-037-15.
- Reason
- Failed dissolution specifications.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/59323398-c823-4a59-9c7c-53502b545fab