Drug recall D-1388-2012

Class II Terminated reported Jun 27, 2012

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

Reason for recall

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.

Lots and codes

Lot #: 11-122-DK, Exp 10/13

Recall details

Recalling firm
Abbott Laboratories, Abbott Park, IL
Quantity
121,000 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 14, 2012
Terminated
December 3, 2012

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