FDA-Drug2017-11-29Class III
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.
West-Ward Pharmaceuticals Corp.
Hazard
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Sold states
Nationwide in the USA and Puerto Rico
Affected count
16,157 shelf packs
Manufactured in
401 Industrial Way West, N/A, Eatontown, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief