Drug product
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
D-0852-2020
Product summary
- Event
- Event 84910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30432 bottles
- Official record key
drug-enforcement:D-0852-2020
Official wording
Reason: Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Code information: Lot #: SM8719040-A, Exp. Date 02/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance