Enforcement Report - Week of June 27, 2012
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Product Detail
| 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 |
|---|---|
| Recall Number | D-1388-2012 |
| Classification | Class II |
| Code Info | Lot #: 11-122-DK, Exp 10/13 |
| Product Distributed Qty | 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. |
Event Detail
| Event Id | 61878 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Abbott Laboratories |
| City | Abbott Park |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-14 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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