Drug recall D-0094-2018
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).
Lots and codes
Lot #: 106352, Exp 10/18
Recall details
- Recalling firm
- West-Ward Pharmaceuticals Corp., Eatontown, NJ
- Quantity
- 1,896 shelf packs
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 6, 2017
- Terminated
- April 1, 2020
Related products
- Dexamethasone Sodium Phosphate – drug information
- NDC 0641-6146 Dexamethasone Sodium Phosphate · Dexamethasone Sodium Phosphate 4 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-6145 Dexamethasone Sodium Phosphate · Dexamethasone Sodium Phosphate 4 mg/mL · Hikma Pharmaceuticals USA Inc.
- NDC 0641-0367 Dexamethasone Sodium Phosphate · Dexamethasone Sodium Phosphate 10 mg/mL · Hikma Pharmaceuticals USA Inc.