FDA Drug recall D-1388-2012
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc
- FDA Drug
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc by Abbott Laboratories, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1388-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-14 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
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
Reason
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.
Identifiers
| ndc | 0074-4637-01 |
|---|---|
| ndc | 0074-1658-01 |
| ndc | 0074-1658-05 |
| code_info | Lot #: 11-122-DK, Exp 10/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1388-2012%22
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