FDA Drug recall D-0093-2018
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…
- FDA Drug
- Class III
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class III recall of 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… by West Ward Pharmaceuticals, citing failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0093-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-06 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceuticals |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Identifiers
| ndc | 0641-0367-21 |
|---|---|
| ndc | 0641-0367-25 |
| ndc | 0641-6145-01 |
| ndc | 0641-6145-25 |
| ndc | 0641-6146-01 |
| ndc | 0641-6146-10 |
| ndc | 0641-6146-25 |
| code_info | Lot #: 106390, 106393, 106395, Exp 10/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0093-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.