FDAFDA · Food and drugs·Recall number D-1125-2017
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.
Published September 6, 2017 · Recall initiated: August 10, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico.
- Lot
- Batch #: KH60276, Exp 10/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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