Reported Aug 8, 2012 · Terminated

OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only,…

Cadence Pharmaceuticals

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cadence Pharmaceuticals · 12481 High Bluff Dr Ste 200 · San Diego, CA · 92130-3583

Is this the product you have?

  • OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only
  • Manufactured forCadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7
Lot codes and dates
    • 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
Amount recalled
1,098,912 vials

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 4, 2013 · Data as of Sep 19, 5:48 PM UTC

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