Drug 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
D-1406-2020
Product summary
- Event
- Event 85960
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,928 bottles
- Official record key
drug-enforcement:D-1406-2020
Official wording
Reason: Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Code information: Lot # F802189, Exp 10/2020, F900240, Exp 1/2021
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent