Status
Terminated
Drug Enforcement D-1388-2012
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.
Classification
Class II
Report Date
June 27, 2012
Termination Date
December 3, 2012
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Abbott Laboratories
- Address
-
100 Abbott Park Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1388-2012
- Event ID
- 61878
- Recall initiation date
- May 14, 2012
- Center classification date
- June 18, 2012
- Code info
- Lot #: 11-122-DK, Exp 10/13
- More code info
- —