D-0426-2018 Class III Terminated
FDA drug recall D-0426-2018 was initiated by Fresenius Kabi USA, LLC on Jan 16, 2018 and is designated Class III. Reason for recall: Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station. The recall status is terminated (terminated Sep 17, 2019). Affected quantity: 35,620 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 7, 2018
- Initiation Date
- Jan 16, 2018
- Termination Date
- Sep 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,620 vials
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.
Distribution Pattern
Nationwide USA
Code Information
Lot #: ZG603, Exp 11/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0426-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026