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U.S. Department of Health and Human Services

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.