Recalls / Class III
Class IIID-0426-2018
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
- Brand name
- Vecuronium Bromide
- Generic name
- Vecuronium Bromide
- Active ingredient
- Vecuronium Bromide
- Route
- Intravenous
- NDCs
- 63323-781, 63323-782
- FDA application
- ANDA205390
- Affected lot / code info
- Lot #: ZG603, Exp 11/18
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.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 35,620 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-01-16
- FDA classified
- 2018-02-15
- Posted by FDA
- 2018-02-07
- Terminated
- 2019-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0426-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.