Vecuronium bromide for Injection — Class III drug recall D-0426-2018
Terminated recall by Fresenius Kabi USA, LLC, reported 2018-02-07, distributed nationwide. Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at
| Recall number | D-0426-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2018-01-16 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 35,620 vials |
| Reason classes | specification failure |
| NDC | 63323-0781-10 |
| Lot numbers | 11/18, ZG603 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0426-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.