Drug 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.
D-0094-2018
Product summary
- Event
- Event 78415
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,896 shelf packs
- Official record key
drug-enforcement:D-0094-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Code information: Lot #: 106352, Exp 10/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification