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New England Life Care, Inc. dba Advanced Compounding Solutions FDA Recalls

5 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste Class IIJul 10, 2023CGMP Violations- that spaces adjacent to the production area	CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of producti	Class IIDrugs	Jul 10, 2023
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced CompoundiClass IIJul 10, 2023CGMP Violations- that spaces adjacent to the production area	CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of producti	Class IIDrugs	Jul 10, 2023
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 ConstitutiClass IIJul 10, 2023CGMP Violations- that spaces adjacent to the production area	CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of producti	Class IIDrugs	Jul 10, 2023
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced CompoundiClass IIJul 10, 2023CGMP Violations- that spaces adjacent to the production area	CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of producti	Class IIDrugs	Jul 10, 2023
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions,Class IIIMay 22, 2023Product Mix up; Product was compounded in 250 mL 5% Dextrose	Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride	Class IIIDrugs	May 22, 2023

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