Cadence Pharmaceuticals Recalls OFIRMEV Acetaminophen Injection Due to Particulate Matter
Cadence Pharmaceuticals is recalling OFIRMEV (acetaminophen) injection vials due to the visible presence of particulate matter.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural defect.
Plain-English summary
Cadence Pharmaceuticals is recalling OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton. The recall was initiated because of the visible presence of particulate matter in the product.
The affected product is prescription-only and was distributed nationwide. The recall covers 1,098,912 vials across multiple lot numbers with expiration dates ranging from July 2012 to September 2012.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be returned to the supplier or the manufacturer for disposal or credit.
The recalled product
- 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.
- Manufacturer
- Cadence Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,098,912
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #: V006015
- V006023
- V006031
- V006056
- V006064
- V006080
- V006106
- V006114
- V006130
- V006148
- V006155
- Exp 07/12
- V006171
- V006189
- V006197
- V006205
- V006213
- V006221
- V006254
- V006262
Distribution
Distributed nationwide across the United States.
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