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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description 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
Recall Number D-1388-2012
Classification Class II
Code Info Lot #: 11-122-DK, Exp 10/13
Product Distributed Qty 121,000 vials
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.

Event Detail

Event Id 61878
Product Type Drugs
Status Ongoing
Recalling Firm Abbott Laboratories
City Abbott Park
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide