Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Reported: February 7, 2018 Initiated: January 16, 2018 #D-0426-2018
Product Description
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Reason for Recall
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 35,620 vials
- Distribution
- Nationwide USA
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10. Recalled by Fresenius Kabi USA, LLC. Units affected: 35,620 vials.
Why was this product recalled? ▼
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Low. Recall number: D-0426-2018.
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