D-0094-2018 Class III Terminated
FDA drug recall D-0094-2018 was initiated by West-Ward Pharmaceuticals Corp. on Nov 6, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). The recall status is terminated (terminated Apr 1, 2020). Affected quantity: 1,896 shelf packs.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 29, 2017
- Initiation Date
- Nov 6, 2017
- Termination Date
- Apr 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,896 shelf packs
Product description
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.
Reason for recall
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Distribution pattern
Nationwide in the USA and Puerto Rico
Code information
Lot #: 106352, Exp 10/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0094-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026