Drug product
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
D-0561-2024
Product summary
- Event
- Event 94750
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34,448 bottles
- Official record key
drug-enforcement:D-0561-2024
Official wording
Reason: Subpotent Drug
Code information: Lot #: 100047634 Exp. Date 4/2025; 35449379A, Exp. Date 7/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent