PlainRecalls
FDA Drug Moderate 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.

Reported: September 6, 2017 Initiated: August 10, 2017 #D-1125-2017

Product Description

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.

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.

Details

Units Affected
7332 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Location
Morton Grove, IL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Morton Grove Pharmaceuticals, Inc.. Units affected: 7332 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 6, 2017. Severity: Moderate. Recall number: D-1125-2017.

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