New England Life Care, Inc. dba Advanced Compounding Solutions 2023-07-26 Health serious FDA
Health · FDA · Recall #FDA-D-0928-2023
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding… Recall
Issued July 26, 2023 · New England Life Care, Inc. dba Advanced Compounding Solutions
In July 2023, New England Life Care, Inc. dba Advanced Compounding Solutions recalled the ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
What you should do
- 1 Stop using ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact New England Life Care, Inc. dba Advanced Compounding Solutions to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Category
- Health
- Recall date
- July 26, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0928-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- New England Life Care, Inc. dba Advanced Compounding Solutions has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.