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Class II · ModerateRecall completed

Amoxicillin and Clavulanate Potassium for Oral Suspension

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch #: KH60276, Exp 10/18
Where it was soldNationwide in the USA and Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054 foreign manufacturer
Distributed by / forWockhardt USA, LLC, Parsippany, NJ 07054
NDC60432-065-00
Show the full FDA record
Full product labelAmoxicillin 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.
Recalling firmMorton Grove Pharmaceuticals, Inc.
DistributionNationwide in the USA and Puerto Rico.
Quantity7332 bottles
Recall initiated2017-08-10
Report date2017-09-06
Recall completed2018-09-13
Recall numberD-1125-2017
ClassificationClass II
FDA statusTerminated
Origin on fileMorton Grove IL United States

Related

Amoxicillin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.