Reported Sep 6, 2017 · Terminated

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted)…

Morton Grove Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Morton Grove Pharmaceuticals, Inc. · 6451 Main St · Morton Grove, IL · 60053-2633

Is this the product you have?

  • Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only
  • Manufactured ByCipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India
  • Manufactured ForWockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00
Lot codes and dates
    • Batch #: KH60276
    • Exp 10/18
Amount recalled
7332 bottles

Where it was sold

  • Nationwide
  • PR

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 13, 2018 · Data as of Sep 19, 6:36 PM UTC

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