Recalls / Class II
Class IID-0648-2024
Product
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Brand name
- Cefixime
- Generic name
- Cefixime
- Active ingredient
- Cefixime
- Route
- Oral
- NDCs
- 68180-405, 68180-407, 68180-416, 68180-423
- FDA application
- ANDA065129
- Affected lot / code info
- Lot #: F201517, Exp 11/30/2024
Why it was recalled
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 4554 bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-08-21
- FDA classified
- 2024-08-26
- Posted by FDA
- 2024-09-04
- Terminated
- 2025-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0648-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.