Vecuronium Bromide for Injection Recalled for Manufacturing Temperature Deviation
McKesson Medical-Surgical is recalling Vecuronium Bromide for Injection (10 mg) manufactured by Teva Pharma USA due to cGMP deviations involving temperature abuse during production. The product was distributed nationwide; no illnesses have been reported.
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: FDA Class II designation indicates potential for adverse consequences. Manufacturing deviations involving temperature abuse during drug production could compromise medication quality and integrity. No illnesses or adverse events reported to date.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Vecuronium Bromide for Injection, 10 mg (1 mg/mL), in 10-vial boxes, manufactured by Teva Pharma USA. The FDA identified Current Good Manufacturing Practice (cGMP) deviations during the manufacturing process.
The deviations involve temperature abuse during production. Temperature control issues during drug manufacturing can affect the quality and stability of the medication.
The recall affects approximately 20 cartons, each containing 10 vials, distributed nationwide. McKesson Medical-Surgical has stated it cannot identify specific lot numbers for individual customers; however, each customer letter includes the distribution date and the dates when affected product may have been shipped to that customer.
No illnesses or adverse events have been reported in connection with this recall. Healthcare providers and patients who have received this product should contact McKesson Medical-Surgical or their pharmaceutical supplier for guidance.
The recalled product
- Product
- Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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