OFIRMEV — Class II drug recall D-1432-2012
Terminated recall by Cadence Pharmaceuticals, reported 2012-08-08, distributed nationwide. Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
| Recall number | D-1432-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cadence Pharmaceuticals, San Diego, CA, United States |
| Recall initiated | 2012-07-24 |
| Classified | 2012-07-31 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,098,912 vials |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00343825102017 |
| NDC | 43825-0102-01 |
| Lot numbers | 07/12, 08/12, 09/12, V006015, V006023, V006031, V006056, V006064, V006080, V006106, V006114, V006130, V006148, V006155, V006171, V006189, V006197, V006205, V006213, V006221, V006254, V006262, V006270, V006296, V006304, V006312, V006320, V006338, V006346, V006353, V006361, V006379, V006387, V006395, V006403, V006429, V006437, V006445, V006460, V006494 and 4 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1432-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.