Status
Terminated
Drug Enforcement D-264-2013
Discoloration; Product may not meet specifications for color description once reconstituted.
Classification
Class III
Report Date
April 24, 2013
Termination Date
September 11, 2013
Product Information
- Product description
- 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.
- Product quantity
- 64,368 bottles
- Reason for recall
- Discoloration; Product may not meet specifications for color description once reconstituted.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Address
-
111 S Calvert St Fl 21st, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-264-2013
- Event ID
- 64325
- Recall initiation date
- January 31, 2013
- Center classification date
- April 18, 2013
- Code info
- Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
- More code info
- —