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Recall Observatory FDA recall evidence

Drug 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

D-0928-2023

July 10, 2023

Class II

Product summary

Firm
New England Life Care, Inc. dba Advanced Compounding Solutions
Event
Event 92690
Status
Terminated
Classification
Class II
Quantity
500 Syringes
Official record key
drug-enforcement:D-0928-2023

Official wording

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

Code information: Lot # 20230524-530F73, Exp 21OCT2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Violations