Why it was recalled
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1432-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2012
- FDA report date
- Aug 8, 2012
- Quantity
- 1,098,912 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cadence Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1432-2012, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62643
- Address
- 12481 High Bluff Dr Ste 200
- Code information
- 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.
- Postal code
- 92130-3583
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1432-2012
- Classification
- Class II
- Recalling firm
- Cadence Pharmaceuticals
- Product quantity
- 1,098,912 vials
- Termination date
- Nov 4, 2013
- Reason for recall
- Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 24, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2012