Recalls / Class II
Class IID-0390-2021
Product
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 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 #: F900787, Exp. Date 4/2021
Why it was recalled
Subpotent Drug
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
- 3,138 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-04-29
- FDA classified
- 2021-05-19
- Posted by FDA
- 2021-05-26
- Terminated
- 2022-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0390-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.