Drug product
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
D-0151-2026
Product summary
- Event
- Event 97795
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4680 cartons
- Official record key
drug-enforcement:D-0151-2026
Official wording
Reason: Subpotent drug; Clavulanate Potassium component
Code information: Lot # 100062316, Exp Date: 01/2026
Distribution pattern: Distributed in three (3) States: MS, OH, CA.
Derived failure modes
-
Potency or specification failure
Subpotent