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.

Recall Number: D-0093-2018

Firm: West-Ward Pharmaceuticals Corp.

Classification: Class III

Status: Terminated

Report Date: 20171129

Initiation Date: 20171106

Termination Date: 20200401

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

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.