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FDARecalled Jul 26, 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

Hazard

Class II — temporary health risk

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Description

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Classification: Class II Distribution: Nationwide in the USA

Product details

Product
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
Type
Drugs
Manufacturer
New England Life Care, Inc. dba Advanced Compounding Solutions
Model numbers
20230524-530F73
UPCs