Recalls / Class II
Class IID-1438-2012
Product
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 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 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
- 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) 112161.1, 112162.1, 112163.1, Exp 05/13; b) 102165.2, 102167.1, Exp 05/12; 102190.1, 102191.1, 102191.2, 102192.1, 102213.1, Exp 07/12; 102240.1, 102241.1, 10227.1, 102272.1, 102272.2, 102273.1, 102274.1, 102275.1, Exp 09/12; 102319.1, 102320.1, 102321.1, 102322.1, 102323.1, 102324.1, 102325.1, Exp 11/12; 102342.1, 102343.1, 102344.1, 102345.1, Exp 12/12; 112019.1, 112020.1, 112021.1, 112022.1, 112023.1, Exp 01/13; 112156.1, 112157.1, 112158.1, 112159.1, 112160.1, Exp 05/13; 112164.1, Exp 06/13; 112203.1, 112204.1, 112205.1, 112206.1, Exp 07/13; 112262.1, 112263.1, Exp 09/13; 112301.1, 112302.1, 112303.1, 112304.1, Exp 10/13; 112323.1, 112324.1, 112325.1, Exp 11/13
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) 74,960 vials; b) 911,070 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-1438-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.