Fresenius Kabi Recalls Vecuronium Bromide Vials Due to Impurity Failure
Fresenius Kabi USA is recalling 35,620 vials of Vecuronium bromide for Injection due to an out-of-specification result for a related compound.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or minor specification issues.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 35,620 vials of Vecuronium bromide for Injection, 10 mg vials, Rx only. The product is manufactured for Fresenius Kabi in Lake Zurich, IL, and made in India. The specific lot number is ZG603 with an expiration date of 11/18. The NDC number is 63323-781-10.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, there was an out-of-specification (OOS) result for USP related compound F at the 12-month stability test station. The agency has classified this recall as Class III.
The product was distributed nationwide in the USA. Healthcare providers and patients should stop using the affected lot and contact their supplier or the recalling firm for further instructions.
The recalled product
- Product
- Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 35,620
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 #: ZG603
- Exp 11/18
Distribution
Distributed nationwide across the United States.
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