The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1438-2012·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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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. The hazard is the presence of particulate matter, which is a quality defect. No illnesses or injuries are reported in the source text, and the risk is not explicitly described as likely to cause serious health consequences, fitting the Moderate criteria for low-risk contamination or precautionary recalls.

Plain-English summary

West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL. The product is packaged in 10 mL single-dose vials and is available under the labels NOVAPLUS and West-Ward. The recall involves 74,960 vials of the NOVAPLUS label and 911,070 vials of the West-Ward label.

The recall was initiated due to the discovery of particles in the stability samples and retain samples. The source text does not specify the nature of the particles or report any illnesses or injuries associated with the product. All affected lots were distributed throughout the US.

Consumers and healthcare providers should stop using the affected lots and contact West-Ward Pharmaceutical Corp. for further instructions. The specific lot numbers and expiration dates are listed in the recall documentation.

The recalled product

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

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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