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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62643
Product Type Drugs
Status Ongoing
Recalling Firm Cadence Pharmaceuticals
City San Diego
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-24
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7. Lot #: V006015, V006023, V006031, V006056, V006064, V006080, V006106, V006114, V006130, V006148, V006155, Exp 07/12; V006171, V006189, V006197, V006205, V006213, V006221, V006254, V006262, V006270, V006296, V006304, V006312, V006320, V006338, V006346, V006353, V006361, V006379, V006387, V006395, Exp 08/12; V006403, V006429, V006437, V006445, V006460, V006494, V006510, V006528, V006536, V006544, Exp 09/12. Class II Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter. 1,098,912 vials D-1432-2012