West-Ward Pharmaceuticals recalls
FDA enforcement reports naming West-Ward Pharmaceuticals Corp. as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Nov 29, 2017
- Nov 29, 2017Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01),…Drug · West-Ward Pharmaceuticals Corp.Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).Class III
- Nov 29, 2017Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 06…Drug · West-Ward Pharmaceuticals Corp.Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).Class III
- Dec 14, 2016SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62Drug · West-Ward Pharmaceuticals Corp.Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.Class III
- Nov 30, 2016Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, MfdDrug · West-Ward Pharmaceuticals Corp.Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time pointClass II
- Nov 30, 2016Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only,…Drug · West-Ward Pharmaceuticals Corp.Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.Class III
- Sep 28, 2016Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstitute…Drug · West-Ward Pharmaceuticals Corp.Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.Class III