Amoxicillin and Clavulanate Potassium for Oral Suspension recalled over foreign material

Recall date

August 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Morton Grove Pharmaceuticals, Inc. recalls Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottl…

Recall number

D-1125-2017

FDA classification

Class II

Brand / firm

Morton Grove Pharmaceuticals, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.