US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 24, 2012 (14 years ago)

OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.

What was recalled

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.

Recalling firm
Cadence Pharmaceuticals
NDC code
43825-102-01
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1432-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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