Recalls / Class II
Class IID-0332-2021
Product
Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.
- Brand name
- Cefprozil
- Generic name
- Cefprozil
- Active ingredient
- Cefprozil
- Route
- Oral
- NDCs
- 68180-401, 68180-402
- FDA application
- ANDA065261
- Affected lot / code info
- Lot Numbers: a) F801122, exp. date June 2021; b) F801123, exp. date June 2021; c) F801124, exp. date June 2021
Why it was recalled
Superpotent 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
- a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2021-03-26
- FDA classified
- 2021-04-12
- Posted by FDA
- 2021-04-21
- Terminated
- 2021-12-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0332-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.