CLASS II Drug recall · Reported 8 Aug 2012 · FDA Enforcement Report

Fosphenytoin Sodium Injection, USP, 500 mg PE recalled

West-ward Pharmaceutical is recalling Fosphenytoin Sodium Injection, USP, 500 mg PE per (50 mg PE per mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 13 Apr 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #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

NDC0143-9782, 0143-9788

Quantity recalleda) 74,960 vials; b) 911,070 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1438-2012
FDA event ID: 62627
Recalling firm: West-ward Pharmaceutical, Eatontown, NJ
Brand: Fosphenytoin Sodium
Manufacturer: West-Ward Pharmaceuticals Corp
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2012
FDA classified: 2 Aug 2012
Reported: 8 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

13 Apr 2012	Recall initiated by company
2 Aug 2012	Classified by FDA	+111 days
8 Aug 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Product as listed by the FDA

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).

Where it was distributed

All lots were distributed throughout the US.

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Which lots are affected?

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

Where was it sold?

All lots were distributed throughout the US.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 62627

Reported	Class	Recall	Company	Reason	Where
8 Aug 2012	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin Sodium	West-ward Pharmaceutical	Particulate Matter	Nationwide

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Other Fosphenytoin recalls

All 6

Reported	Class	Recall	Company	Reason	Where
4 Apr 2018Drug	CLASS II	Fosphenytoin Sodium Injection, USP 500 mg PE* recalled	Amneal Pharmaceuticals	Particulate Matter	Nationwide
22 Nov 2017Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalled	Amneal Pharmaceuticals	Particulate Matter	5 states
16 Jul 2014Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 500 mg PE recalledFosphenytoin	Fresenius Kabi USA	Particulate Matter	Nationwide
16 Jul 2014Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin	Fresenius Kabi USA	Particulate Matter	Nationwide
8 Aug 2012Drug	CLASS II	Fosphenytoin Sodium Injection, USP, 100 mg PE recalledFosphenytoin Sodium	West-ward Pharmaceutical	Particulate Matter	Nationwide