Status
Terminated
Drug Enforcement D-1432-2012
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Classification
Class II
Report Date
August 8, 2012
Termination Date
November 4, 2013
Product Information
- Product description
- 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.
- Product quantity
- 1,098,912 vials
- Reason for recall
- Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Cadence Pharmaceuticals
- Address
-
12481 High Bluff Dr Ste 200, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1432-2012
- Event ID
- 62643
- Recall initiation date
- July 24, 2012
- Center classification date
- July 31, 2012
- Code info
- 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.
- More code info
- —