Reported Feb 7, 2018 · Terminated
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India,…
Fresenius Kabi USA, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd
- forFresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
- Lot codes and dates
Lot #: ZG603Exp 11/18
- Amount recalled
- 35,620 vials
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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