Recalls / Class II
Class IID-1437-2012
Product
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
- Brand name
- Fosphenytoin Sodium
- Generic name
- Fosphenytoin Sodium
- Active ingredient
- Fosphenytoin Sodium
- Route
- Intramuscular, Intravenous
- NDCs
- 0143-9782, 0143-9788
- FDA application
- ANDA078765
- Affected lot / code info
- Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13
Why it was recalled
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Manufacturer
- West-Ward Pharmaceuticals Corp
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- a) 308,275 vials; b) 2,008,850 vials
- Distribution pattern
- All lots were distributed throughout the US.
Timeline
- Recall initiated
- 2012-04-13
- FDA classified
- 2012-08-02
- Posted by FDA
- 2012-08-08
- Terminated
- 2015-01-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1437-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.