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New England Life Care, Inc. dba Advanced Compounding Solutions recalls ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste

Recalled July 26, 2023 · FDA recall D-0928-2023 · New England Life Care, Inc.

Hazard
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. · FDA Class II
Units
500 Syringes
Sold at
Nationwide in the USA

Description

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

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
Manufacturer(s)
New England Life Care, Inc. dba Advanced Compounding Solutions

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

New England Life Care, Inc. dba Advanced Compounding Solutions recalls ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste | RecallWatchUSA