Recalls / Class II
Class IID-0497-2024
Product
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- Lot # F305292, Exp 8/30/2025
Why it was recalled
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
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
- 17,040 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2024-04-24
- FDA classified
- 2024-05-14
- Posted by FDA
- 2024-05-22
- Terminated
- 2025-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0497-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.