Drug 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.
D-264-2013
Product summary
- Event
- Event 64325
- Status
- Terminated
- Classification
- Class III
- Quantity
- 64,368 bottles
- Official record key
drug-enforcement:D-264-2013
Official wording
Reason: Discoloration; Product may not meet specifications for color description once reconstituted.
Code information: Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
may not meet specifications