Drug recall: SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constituti
FDA enforcement event 92690 is a drug recall by New England Life Care, Inc. dba Advanced Compounding Solutions of Woburn, MA, initiated 10 Jul 2023 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 4 Dec 2023. Initiation: voluntary: firm initiated. New England Life Care, Inc. dba Advanced Compounding Solutions has 2 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
New England Life Care, Inc. dba Advanced Compounding Solutions, Woburn, MA.
Reason for recall
"CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0926-2023 | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10 | 493 syringes | Class II | Terminated | 26 Jul 2023 |
| D-0927-2023 | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25; | 82 Bags | Class II | Terminated | 26 Jul 2023 |
| D-0928-2023 | ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05 | 500 Syringes | Class II | Terminated | 26 Jul 2023 |
| D-0929-2023 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50; | 209 Bags | Class II | Terminated | 26 Jul 2023 |
Context
Other enforcement events for New England Life Care, Inc. dba Advanced Compounding Solutions
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 May 2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, (92374) | Drug | Class III | 1 |
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Dec 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.