Multi event Drug Recall Enforcement Report Class III voluntary initiated by West-Ward Pharmaceuticals Corp., originally initiated on 11-06-2017 for the product 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. The product was recalled due to failed impurities/degradation specifications: high out of specification results for dexamethasone adduct (related compound).. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0093-2018 | 11-06-2017 | 11-29-2017 | Class III | 16,157 shelf packs | 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. | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). | Terminated |
| D-0094-2018 | 11-06-2017 | 11-29-2017 | Class III | 1,896 shelf packs | 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. | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0641-0367 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Injection | Intramuscular; Intravenous | Hikma Pharmaceuticals Usa Inc. | Human Prescription Drug |
| 0641-6145 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Injection | Intra-articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | Hikma Pharmaceuticals Usa Inc. | Human Prescription Drug |
| 0641-6146 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Injection | Intra-articular; Intralesional; Intramuscular; Intravenous; Soft Tissue | Hikma Pharmaceuticals Usa Inc. | Human Prescription Drug |
