Advanced Compounding Solutions recalls specific ROcuronium Bromide 50mg/5mL syringes due to potential contamination risks from production area spaces. This recall affects certain lots manufactured in Woburn, MA.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Advanced Compounding Solutions has recalled specific ROcuronium Bromide 50mg/5m: syringes due to potential contamination risks from production area spaces. This recall affects certain lots manufactured in Woburn, MA. Patients using these syringes should contact their healthcare provider for guidance.
The recall is due to CGMP violations where spaces adjacent to the production area may have been compromised during manufacturing. This could potentially lead to contamination of the medication. However, the exact risk level is not clearly specified in the recall notice.
Healthcare providers and patients using the recalled ROcuronium Bromide 50mg/5mL syringes for medical procedures. Those with the specific lot number 20230524-530F73 are most at risk.
Check for the lot number 20230524-530F73 on the syringe packaging. The product is labeled as ROcuronium Bromide 50 mg/5 mL (10 mg/mL), 5mL Syringe, RX Only, manufactured by Advanced Compounding Solutions in Woburn, MA.
Patients using the recalled product should contact their healthcare provider for guidance on next steps.
The recall indicates potential contamination risks, but the exact safety level is not clearly stated in the official notice.
The specific lot number for this recall is 20230524-530F73.
Check the syringe packaging for the lot number 20230524-530F73 and the product description ROcuronium Bromide 50 mg/5 mL (10 mg/mL), 5mL Syringe, RX Only.
We’ve drafted a message you can send Advanced Compounding Solutions to request your refund or repair — edit it as you like.
Subject: Recall D-0928-2023 — Advanced Compounding Solutions Advanced Compounding Solutions Hello, I own a Advanced Compounding Solutions that is covered by recall D-0928-2023 from Advanced Compounding Solutions. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
