Recalls / Class II
Class IID-0274-2024
Product
Cefixime for Oral Suspension 100mg/5mL, 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 #: F304833, Exp 06/2025
Why it was recalled
Failed Impurities/Degradation Specifications
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
- 4,608 Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-03
- FDA classified
- 2024-01-26
- Posted by FDA
- 2024-02-07
- Terminated
- 2024-12-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0274-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.