FDA-Drug2023-07-26Class II

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

New England Life Care, Inc. dba Advanced Compounding Solutions
Hazard

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Sold states
Nationwide in the USA
Affected count
500 Syringes
Manufactured in
4 Constitution Way Ste L, N/A, Woburn, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0928-2023

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