Rocuronium Bromide Injectable Recalled Due to CGMP Violations
Advanced Compounding Solutions is recalling Rocuronium Bromide 10 mg/mL injectables (lot #20230524-530F73) nationwide due to CGMP violations. Production spaces adjacent to the manufacturing area may have been compromised.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a compounded injectable drug with CGMP violations affecting the production environment. Injectable drugs are risk-of-harm products, and injury has not yet been reported, qualifying this as High severity.
Plain-English summary
Advanced Compounding Solutions is recalling Rocuronium Bromide 50 mg/5 mL (10 mg/mL) supplied in 5 mL syringes. The U.S. Food and Drug Administration (FDA) initiated this Class II recall.
The recall is issued due to current Good Manufacturing Practice (CGMP) violations. The specific concern is that spaces adjacent to the production area may have been compromised at the time of production.
The affected lot is #20230524-530F73 (expiration October 21, 2023). 500 syringes were distributed nationwide in the USA. Patients and healthcare providers should consult with their healthcare provider regarding use of this product and contact Advanced Compounding Solutions with any questions.
The recalled product
- 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
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Category
- Drug — Compounded Injectable
- Hazard
- cgmp-violation
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20230524-530F73
- Exp 21OCT2023
Distribution
Distributed nationwide across the United States.
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