Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

FDA recall notice · announced February 7, 2018 · Fresenius Kabi

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Notes

Distribution: Nationwide USA
Lot/code information: Lot #: ZG603, Exp 11/18
Quantity: 35,620 vials
Status: Terminated
Products in this recall event:
- Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10 (D-0426-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.