West-Ward Pharmaceuticals Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0094-2018 | Class III | Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), | November 6, 2017 |
| D-0093-2018 | Class III | Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 2 | November 6, 2017 |
| D-0172-2017 | Class III | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per | November 17, 2016 |
| D-0147-2017 | Class III | Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured | November 4, 2016 |
| D-1045-2017 | Class II | Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. | October 3, 2016 |
| D-1515-2016 | Class III | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, | August 18, 2016 |