Drug product
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
D-0376-2019
Product summary
- Event
- Event 81888
- Status
- Terminated
- Classification
- Class II
- Quantity
- 287,784 bottles
- Official record key
drug-enforcement:D-0376-2019
Official wording
Reason: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Code information: a) Lot #: F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b) Lot #: F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations