Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01...
FDA Recall #D-0094-2018 — Class III — November 6, 2017
Product Description
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).
Recalling Firm
West-Ward Pharmaceuticals Corp. — Eatontown, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,896 shelf packs
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot #: 106352, Exp 10/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated