West-Ward Recalls Dexamethasone Sodium Phosphate Injection Due to Impurities
West-Ward Pharmaceuticals is recalling specific lots of Dexamethasone Sodium Phosphate Injection because of high out-of-specification results for a related compound.
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 recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
West-Ward Pharmaceuticals Corp. is recalling 16,157 shelf packs of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01). The affected product is packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25) and is a prescription-only medication. The recall involves lots 106390, 106393, and 106395, which have an expiration date of 10/18.
The recall was initiated because the product failed impurities and degradation specifications, specifically showing high out-of-specification results for a Dexamethasone adduct, which is a related compound. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the USA and Puerto Rico. Healthcare providers and patients should stop using the affected lots and contact West-Ward Pharmaceuticals or their supplier for further instructions or replacement.
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
- 16,157
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 (4)
- Lot #: 106390
- 106393
- 106395
- Exp 10/18
Distribution
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
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