D-1432-2012 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 8, 2012
- Initiation Date
- July 24, 2012
- Termination Date
- November 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,098,912 vials
Product Description
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.
Reason for Recall
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Distribution Pattern
Nationwide
Code Information
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.