Home / Recalls / Morton Grove Pharmaceuticals, Inc. / D-1125-2017

D-1125-2017 Class II Terminated

Recalled by Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL

Recall Details

Product Type
Drugs
Report Date
September 6, 2017
Initiation Date
August 10, 2017
Termination Date
September 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7332 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico.

Code Information

Batch #: KH60276, Exp 10/18

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  • D-1042-2018 Class II — Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle (July 24, 2018)
  • D-0571-2016 Class III — Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, (December 15, 2015)