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.
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