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.

FDA recall notice · announced August 8, 2012 · Cadence Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/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.
Quantity: 1,098,912 vials
Status: Terminated
Products in this recall event:
- 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- (D-1432-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.