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.
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