Drug product
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
D-0868-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 77117
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,464 bottles
- Official record key
drug-enforcement:D-0868-2017
Official wording
Reason: Subpotent Drug; Clavulanic Acid
Code information: Lot FP8735, 8/2017
Distribution pattern: NY, OH
Derived failure modes
-
Potency or specification failure
Subpotent