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Recall Observatory FDA recall evidence

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

May 14, 2012

Class II

Product summary

Firm
Abbott Laboratories
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

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations