Recalls / Class II
Class IID-1125-2017
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 60432-065-00.
- Affected lot / code info
- Batch #: KH60276, Exp 10/18
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.
Recalling firm
- Firm
- Morton Grove Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6451 Main St, N/A, Morton Grove, Illinois 60053-2633
Distribution
- Quantity
- 7332 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2017-08-10
- FDA classified
- 2017-08-29
- Posted by FDA
- 2017-09-06
- Terminated
- 2018-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1125-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.