Drug product
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
D-1388-2012
Product summary
- Event
- Event 61878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121,000 vials
- Official record key
drug-enforcement:D-1388-2012
Official wording
Reason: CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Code information: Lot #: 11-122-DK, Exp 10/13
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations