Zemplar — Class II drug recall D-1388-2012
Terminated recall by Abbott Laboratories, reported 2012-06-27, distributed nationwide. CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreig
| Recall number | D-1388-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2012-05-14 |
| Classified | 2012-06-18 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 121,000 vials |
| Reason classes | cgmp |
| NDC | 00074-1658, 00074-1658-01, 00074-1658-05, 00074-4637, 00074-4637-01 |
| Lot numbers | 10/13, 11-122-DK |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1388-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.