Drug product
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
D-1234-2015
Product summary
- Event
- Event 71409
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,593 vials
- Official record key
drug-enforcement:D-1234-2015
Official wording
Reason: Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Code information: Lot #: 6109469, 6109470, Exp 10/2016
Distribution pattern: Nationwide,Hawaii, and Puerto Rico
Derived failure modes
-
Potency or specification failure
out-of-specification