Class II
Terminated
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.
This recall has been terminated (originally issued September 6, 2017).
- Recall Initiated
- August 10, 2017
- Posted
- September 6, 2017
- Recall Number
- D-1125-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7332 bottles
- Firm Location
- Morton Grove, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Distribution
Nationwide in the USA and Puerto Rico.
Lot / Code Info
Batch #: KH60276, Exp 10/18
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