Dexamethasone Sodium Phosphate Injection — Class III drug recall D-0093-2018
Terminated recall by West-Ward Pharmaceuticals Corp., reported 2017-11-29, distributed nationwide. Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (rela
| Recall number | D-0093-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceuticals Corp., Eatontown, NJ, United States |
| Recall initiated | 2017-11-06 |
| Classified | 2017-11-22 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 16,157 shelf |
| Reason classes | specification failure |
| NDC | 00641-0367, 00641-0367-21, 00641-0367-25, 00641-6145, 00641-6145-01, 00641-6145-25, 00641-6146, 00641-6146-01, 00641-6146-10, 00641-6146-25 |
| Lot numbers | 10/18, 106390, 106393, 106395 |
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 for recall
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0093-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.