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New England Life Care, Inc. dba Advanced Compounding Solutions

Complete recall history across all FDA and CPSC categories — 5 total recalls

New England Life Care, Inc. dba Advanced Compounding Solutions appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (5)

FDA drug safety enforcement actions by New England Life Care, Inc. dba Advanced Compounding Solutions

Date Product Reason Class
Jul 10, 2023 PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60... CGMP Violations- that spaces adjacent to the production area may have been co... Class II
Jul 10, 2023 SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, A... CGMP Violations- that spaces adjacent to the production area may have been co... Class II
Jul 10, 2023 ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Com... CGMP Violations- that spaces adjacent to the production area may have been co... Class II
Jul 10, 2023 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515... CGMP Violations- that spaces adjacent to the production area may have been co... Class II
May 22, 2023 Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Com... Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 m... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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