West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per…
- Recall date
- November 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0093-2018
- FDA classification
- Class III
- Brand / firm
- West-Ward Pharmaceuticals Corp.
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
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