New England Life Care, Inc. Dba Advanced Compounding Solutions FDA Record
- Last warning letter 2023
New England Life Care, Inc. Dba Advanced Compounding Solutions has 5 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. FDA has issued 1 warning letter to New England Life Care, Inc. Dba Advanced Compounding Solutions, the most recent on May 16, 2023.
- Latest recall
- D-0928-2023 · Class II · Jul 10, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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New England Life Care, Inc. Dba Advanced Compounding Solutions FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 16, 2023 · Letter on fda.gov | Compounding Pharmacy/Adulterated Drug Products | Division of Pharmaceutical Quality Operations I |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0928-2023 | Class II | ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4… | Jul 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… | Jul 10, 2023 |
| 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… | Jul 10, 2023 |
| D-0926-2023 | Class II | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding… | Jul 10, 2023 |
| D-0778-2023 | Class III | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced… | May 22, 2023 |
New England Life Care, Inc. Dba Advanced Compounding Solutions and the FDA: common questions
Has New England Life Care, Inc. Dba Advanced Compounding Solutions received an FDA warning letter?
Yes. FDA has issued 1 warning letter to New England Life Care, Inc. Dba Advanced Compounding Solutions. The most recent is dated May 16, 2023, with the subject "Compounding Pharmacy/Adulterated Drug Products".
Has New England Life Care, Inc. Dba Advanced Compounding Solutions received an FDA Form 483?
FDA has not published a Form 483 for "New England Life Care, Inc. Dba Advanced Compounding Solutions" in its reading room. FDA publishes some Form 483s, not all of them.
Has New England Life Care, Inc. Dba Advanced Compounding Solutions had an FDA recall?
Yes. New England Life Care, Inc. Dba Advanced Compounding Solutions has 5 FDA recalls on record. The most recent started Jul 10, 2023.
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