Recalls / Class III
Class IIID-264-2013
Product
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
- Affected lot / code info
- Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Why it was recalled
Discoloration; Product may not meet specifications for color description once reconstituted.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21st, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 64,368 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-31
- FDA classified
- 2013-04-18
- Posted by FDA
- 2013-04-24
- Terminated
- 2013-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-264-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.