The Recall Desk
HighFDA (Drugs)·D-1125-2017·Announced 2017-09-06

Morton Grove Recalls Amoxicillin and Clavulanate Potassium Oral Suspension

Morton Grove Pharmaceuticals is recalling 7,332 bottles of Amoxicillin and Clavulanate Potassium Oral Suspension due to a customer complaint of a blue nitrile glove fragment found in the product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a physical foreign object (nitrile glove fragment) in a medication, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Morton Grove Pharmaceuticals, Inc. is recalling 7,332 bottles of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted). The product is identified by Batch # KH60276 and an expiration date of 10/18. The medication was manufactured by Cipla Ltd. at Medispray Laboratories Pvt. Ltd. in India for Wockhardt USA, LLC.

The recall was initiated following a customer complaint identifying a blue foreign material in the product, which was determined to be a portion of a nitrile glove. The affected product was distributed nationwide in the USA and Puerto Rico.

Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

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
Affected units
7,332

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Batch #: KH60276
  • Exp 10/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: