West Ward Pharmaceuticals recalls
West Ward Pharmaceuticals appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2017-11-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2016-09-28 to 2017-11-29 |
| By agency | FDA Drug (6) |
| By classification | Class III (5), Class II (1) |
| By status | terminated (6) |
| Distribution named in notices | US |
Recalls
- 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 p…
FDA Drug · Class III · 2017-11-29 · West Ward Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). - 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 · 2017-11-29 · West Ward Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). - SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmace…
FDA Drug · Class III · 2016-12-14 · West Ward Pharmaceuticals
Reason: Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. - Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp
FDA Drug · Class II · 2016-11-30 · West Ward Pharmaceuticals
Reason: Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point - Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 18…
FDA Drug · Class III · 2016-11-30 · West Ward Pharmaceuticals
Reason: Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. - Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals,…
FDA Drug · Class III · 2016-09-28 · West Ward Pharmaceuticals
Reason: Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.