Recalls / Class II
Class IID-1406-2020
Product
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
- Brand name
- Cefdinir
- Generic name
- Cefdinir
- Active ingredient
- Cefdinir
- Route
- Oral
- NDCs
- 68180-722, 68180-723
- FDA application
- ANDA065259
- Affected lot / code info
- Lot # F802189, Exp 10/2020, F900240, Exp 1/2021
Why it was recalled
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
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
- 35,928 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-07-02
- FDA classified
- 2020-07-23
- Posted by FDA
- 2020-07-29
- Terminated
- 2021-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1406-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.