FDA Recalls Rocuronium Bromide Injections Due to Improper Storage
McKesson Medical-Surgical is recalling Rocuronium Bromide Injection vials due to storage outside label specifications. Seventy vials were distributed to three healthcare accounts in New Mexico, Arizona, and Utah.
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 recall due to improper storage of injectable medication. Although no illnesses or injuries have been reported, storage deviations of injectable products present a recognized risk-of-harm scenario that could compromise product sterility and efficacy.
Plain-English summary
Rocuronium Bromide Injection, 10 mg/mL, multiple-dose vials, is being recalled due to improper storage outside the drug label specifications. The affected product has batch code 1064081.
The recall involves 70 vials distributed to three direct accounts in New Mexico, Arizona, and Utah.
Healthcare providers who have received this product should discontinue use and quarantine the affected vials. Contact McKesson Medical-Surgical for return instructions and replacement product.
The recalled product
- Product
- ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
- Brand
- ROCURONIUM BROMIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable
- Hazard
- improper-storage
- manufacturing-deviation
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 (1)
- 1064081
UPCs (2)
- 0355150226108
- 0355150225057
Distribution
Distributed in 3 states:
- AZ
- NM
- UT
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