The Recall Desk
LowFDA (Drugs)·D-0094-2018·Announced 2017-11-29

West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurity

West-Ward Pharmaceuticals is recalling Dexamethasone Sodium Phosphate Injection due to high levels of a related compound impurity.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

West-Ward Pharmaceuticals Corp. is recalling 1,896 shelf packs of Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01). The affected product is Lot #106352 with an expiration date of 10/18. The recall was initiated because the product failed impurities/degradation specifications, specifically showing high out-of-specification results for a Dexamethasone adduct, which is a related compound.

The recalled product was distributed nationwide in the USA and Puerto Rico. It is a prescription-only medication administered via intramuscular or intravenous routes. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Healthcare providers and patients should discontinue use of the affected lot and return the product to the distributor or manufacturer for credit. Consumers should check their medication vials for the specific lot number and expiration date listed above.

The recalled product

Product
DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
Brand
DEXAMETHASONE SODIUM PHOSPHATE
Manufacturer
West-Ward Pharmaceuticals Corp.
Category
Drug — Injection
Hazard
Affected units
1,896

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 (2)

  • Lot #: 106352
  • Exp 10/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by West-Ward Pharmaceuticals 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 · DEXAMETHASONE SODIUM PHOSPHATE

Same manufacturer · West-Ward Pharmaceuticals Corp.

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Same hazard · impurity

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