Class III
Terminated
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.
- Company
- West-Ward Pharmaceuticals Corp.
- Recall Initiated
- November 6, 2017
- Posted
- November 29, 2017
- Recall Number
- D-0093-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,157 shelf packs
- Firm Location
- Eatontown, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot #: 106390, 106393, 106395, Exp 10/18
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