Drug product
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
D-0290-2015
Product summary
- Event
- Event 69810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 92,125 vials
- Official record key
drug-enforcement:D-0290-2015
Official wording
Reason: Defective Container: Vials may be missing stoppers.
Code information: Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Defective Container: Vials may be missing stoppers.