West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 m
Recalled November 29, 2017 · FDA recall D-0094-2018 · West-Ward Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). · FDA Class III
Units
1,896 shelf packs
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Product
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.
Manufacturer(s)
West-Ward Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →