Recalls / Class II
Class IID-0518-2024
Product
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- Lot #F305184, F305185, F305186, Exp 7/31/ 2025
Why it was recalled
Defective container: lack of seal integrity.
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
- 51,006 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-05-08
- FDA classified
- 2024-05-29
- Posted by FDA
- 2024-06-05
- Terminated
- 2025-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0518-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.