D-264-2013 Class III Terminated
FDA drug recall D-264-2013 was initiated by Lupin Pharmaceuticals Inc. on Jan 31, 2013 and is designated Class III. Reason for recall: Discoloration; Product may not meet specifications for color description once reconstituted. The recall status is terminated (terminated Sep 11, 2013). Affected quantity: 64,368 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 24, 2013
- Initiation Date
- Jan 31, 2013
- Termination Date
- Sep 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64,368 bottles
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.
Reason for Recall
Discoloration; Product may not meet specifications for color description once reconstituted.
Distribution Pattern
Nationwide
Code Information
Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-264-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026