D-1388-2012 Class II Terminated
FDA drug recall D-1388-2012 was initiated by Abbott Laboratories on May 14, 2012 and is designated Class II. 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. The recall status is terminated (terminated Dec 3, 2012). Affected quantity: 121,000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 27, 2012
- Initiation Date
- May 14, 2012
- Termination Date
- Dec 3, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121,000 vials
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 11-122-DK, Exp 10/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1388-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026