FDA Recall Dexamethasone Sodium Phosphate

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Dexamethasone Sodium Phosphate with NDC 0641-0367 was initiated on 11-06-2017 as a Class III recall due to failed impurities/degradation specifications: high out of specification results for dexamethasone adduct (related compound). The latest recall number for this product is D-0093-2018 and the recall is currently terminated as of 04-01-2020 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0093-201811-06-201711-29-2017Class III16,157 shelf packsDexamethasone 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.Terminated
D-0094-201811-06-201711-29-2017Class III1,896 shelf packsDexamethasone 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.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.