Drug product
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
D-1252-2020
Product summary
- Event
- Event 85487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,518 bottles
- Official record key
drug-enforcement:D-1252-2020
Official wording
Reason: Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Code information: Lot #: F800779, Expiry 4/2020
Distribution pattern: Nationwide with the United States and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Subpotent