Prescription Antibiotic Recalled

September 8, 2017

Morton Grove Pharmaceuticals Inc. is recalling 7332 bottles of amoxicillin and clavulanate potassium for oral suspension, USP, 250/62.5 mg per 5 mL, 100 mL when reconstituted (NDC 60432-065-00), according to the September 6, 2017, US Food and Drug Administration (FDA) Enforcement Report.

A consumer found blue foreign material, identified as a piece of a nitrile glove, in the product. As a result, Morton Grove Pharmaceuticals issued a voluntarily recall August 10, 2017, for bottles from batch KH60276, which has an October 2018 expiration.

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The medication was manufactured by Cipla Ltd. at Medispray Laboratories Private Limited for Wockhardt USA. It was distributed across the United States and Puerto Rico.

On August 29, 2017, the FDA designated the recall Class II, which suggests use of the medication could cause temporary or reversible adverse effects. However,  the probability of serious harm, is remote.

Amoxicillin and clavulanate potassium for oral suspension is a prescription medicine for the treatment of certain bacterial infections.

Jolynn Tumolo