Fosphenytoin Sodium Injection, Solution
FDA Recall NDC 0143-9782
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fosphenytoin Sodium (NDC 0143-9782). A significant event, classified as Class II, was initiated on Apr 13, 2012 by West-ward Pharmaceuticals Corp. The reported reason for this action was: "Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Apr 13, 2012
Aug 08, 2012
a) 74,960 vials; b) 911,070 vials
Recall Profile & Regulatory Data
Event ID
62627
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
All lots were distributed throughout the US.
Termination Date
Jan 16, 2015
Product Description
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).
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0143-9788-01Product
0143-9788-25Product
0143-9782-01Product
0143-9782-10Product
0143-9703-10Product
Class II Terminated
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Apr 13, 2012
Aug 08, 2012
a) 308,275 vials; b) 2,008,850 vials
Recall Profile & Regulatory Data
Event ID
62627
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
All lots were distributed throughout the US.
Termination Date
Jan 16, 2015
Product Description
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).
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
0143-9788-01Product
0143-9788-25Product
0143-9782-01Product
0143-9782-10Product
0143-9704-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
