Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01) recall — FDA D-0093-2018
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Overview of recall records associated with West-Ward Pharmaceuticals Corp., including dates, categories and classifications where available.
Classification mix: Class III: 4.
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
This page summarizes recall records in which the official source identifies West-Ward Pharmaceuticals Corp. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.