The Recall Desk
ModerateFDA (Drugs)·D-1437-2012·Announced 2012-08-08

West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural defect, and no injuries or illnesses are reported in the source text.

Plain-English summary

West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vials. The product is distributed under the labels NOVAPLUS (NDC 0143-9704-25) and West-Ward (NDC 0143-9788-25). The recall involves 308,275 vials of the NOVAPLUS label and 2,008,850 vials of the West-Ward label.

The recall was initiated due to the discovery of particles in the stability samples and retain samples. The affected lots were distributed throughout the United States. The specific lot numbers and expiration dates are listed in the recall documentation.

Healthcare providers and patients should discontinue use of the affected lots. Consumers should check their medication vials against the lot numbers provided in the official recall notice and contact their pharmacist or healthcare provider for guidance on replacement or further instructions.

The recalled product

Product
FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
Brand
FOSPHENYTOIN SODIUM
Manufacturer
West-ward Pharmaceutical Corp.
Category
Drug — Anticonvulsant Injection
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by West-ward Pharmaceutical Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · FOSPHENYTOIN SODIUM

Same manufacturer · West-ward Pharmaceutical Corp.

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Same hazard · particulate matter

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