Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Ofirmev
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.
Other Acetaminophen recalls
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Class II · Moderate risk Ongoing
Oxycodone and Acetaminophen CII Tablets USP
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk Ongoing
Tylenol
Reason Defective Container
Class II · Moderate risk Ongoing
Acetaminophen 500mg Caffeine 65mg caplets
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk Ongoing
Acetaminophen Injection 1000 mg/100 mL
Reason Discoloration
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