FDA-Drug2017-11-29Class III
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), 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
1,896 shelf packs
Manufactured in
401 Industrial Way West, N/A, Eatontown, NJ, United States
Products
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2018Don't want to check this manually?
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