Enforcement Report - Week of August 15, 2012
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Product Detail
| Product Description | HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit). |
|---|---|
| Recall Number | D-1444-2012 |
| Classification | Class I |
| Code Info | Lot #07547LL, Exp 07/01/13 |
| Product Distributed Qty | 223,750 prefilled cartridge units |
| Reason For Recall | Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume. |
Event Detail
| Event Id | 61847 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Hospira Inc. |
| City | Lake Forest |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-12 |
| Initial Firm Notification of Consignee or Public | Press Release |
| Distribution Pattern | Nationwide. |
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