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Companies / New England Life Care, Inc. dba Advanced Compounding Solutions
New England Life Care, Inc. dba Advanced Compounding Solutions
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0929-2023 | Class II | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only | July 10, 2023 |
| D-0926-2023 | Class II | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Sol | July 10, 2023 |
| D-0928-2023 | Class II | ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 C | July 10, 2023 |
| D-0927-2023 | Class II | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only | July 10, 2023 |
| D-0778-2023 | Class III | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Co | May 22, 2023 |