Why it was recalled
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Product description
Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.
Lot numbers, UPCs & expiration codes
Lot #s: F300736 Exp. February 2015, F300740 Exp. February 2015, F300741 Exp. February 2015
Where it was sold
Nationwide
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-1187-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 27, 2014
- FDA report date
- Apr 9, 2014
- Quantity
- 5,172 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1187-2014, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 67462
- Address
- 111 S Calvert St Fl 21st
- Code information
- Lot #s: F300736 Exp. February 2015, F300740 Exp. February 2015, F300741 Exp. February 2015
- Postal code
- 21202-6174
- Report date
- Apr 9, 2014
- Product type
- Drugs
- Recall number
- D-1187-2014
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 5,172 bottles
- Termination date
- May 12, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 27, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 2, 2014