FDA recall D-1432-2012

Cadence Pharmaceuticals · Class II · drug

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-07-24
Report date: 2012-08-08
Termination date: 2013-11-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1432-2012