Drug product
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00.
D-1125-2017
Product summary
- Event
- Event 77933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7332 bottles
- Official record key
drug-enforcement:D-1125-2017
Official wording
Reason: Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Code information: Batch #: KH60276, Exp 10/18
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance