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.
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.
Lot numbers, UPCs & expiration codes
Batch #: KH60276, Exp 10/18
Where it was sold
Nationwide in the USA and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1125-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2017
- FDA report date
- Sep 6, 2017
- Quantity
- 7332 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1125-2017, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77933
- Address
- 6451 Main St
- Code information
- Batch #: KH60276, Exp 10/18
- Postal code
- 60053-2633
- Report date
- Sep 6, 2017
- Product type
- Drugs
- Recall number
- D-1125-2017
- Classification
- Class II
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Product quantity
- 7332 bottles
- Termination date
- Sep 13, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Aug 10, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2017