Recalls / Class II
Class IID-1252-2020
Product
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, 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 #: F800779, Expiry 4/2020
Why it was recalled
Subpotent Drug: low out of specification (OOS) test result observed in 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
- 4,518 bottles
- Distribution pattern
- Nationwide with the United States and Puerto Rico.
Timeline
- Recall initiated
- 2020-04-15
- FDA classified
- 2020-04-23
- Posted by FDA
- 2020-04-29
- Terminated
- 2021-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1252-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.