Product: 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.
Reason for recall: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Recall initiated: 20171106
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated