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 | Letter |
| 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 |
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