Recalls / Class III
Class IIID-0306-2020
Product
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20
Why it was recalled
Presence of Foreign substance: identified as a dead ant.
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) 4074 bottles b) 30,300 bottles
- Distribution pattern
- Product was distributed to major distributors/wholesalers throughout the United States.
Timeline
- Recall initiated
- 2019-11-01
- FDA classified
- 2019-11-07
- Posted by FDA
- 2019-11-13
- Terminated
- 2021-03-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0306-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.