PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 27, 2012 Initiated: May 14, 2012 #D-1388-2012

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

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.

Details

Recalling Firm
Abbott Laboratories
Units Affected
121,000 vials
Distribution
Nationwide
Location
Abbott Park, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Abbott Laboratories. Units affected: 121,000 vials.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 27, 2012. Severity: Moderate. Recall number: D-1388-2012.