Recalls / Class II
Class IID-1388-2012
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
- Brand name
- Zemplar
- Generic name
- Paricalcitol
- Active ingredient
- Paricalcitol
- Route
- Intravenous
- NDCs
- 0074-1658, 0074-4637
- FDA application
- NDA020819
- Affected lot / code info
- Lot #: 11-122-DK, Exp 10/13
Why it was 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.
Recalling firm
- Firm
- Abbott Laboratories
- Manufacturer
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Abbott Park Rd, N/A, Abbott Park, Illinois 60064-3502
Distribution
- Quantity
- 121,000 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-05-14
- FDA classified
- 2012-06-18
- Posted by FDA
- 2012-06-27
- Terminated
- 2012-12-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1388-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.