Drug product
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
D-1320-2019
Product summary
- Event
- Event 82939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,408, 60 mL bottles
- Official record key
drug-enforcement:D-1320-2019
Official wording
Reason: Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Code information: Lot # F802335, exp. date November 2020
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
metal piece