Cisatracurium Besylate Injection — Class II drug recall D-0819-2016
Terminated recall by Fresenius Kabi USA, LLC, reported 2016-04-20, distributed nationwide. Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free
| Recall number | D-0819-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2016-04-05 |
| Classified | 2016-04-12 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 94,560 vials |
| Reason classes | undeclared allergen, labeling |
| NDC | 63323-0416, 63323-0416-01, 63323-0416-05, 63323-0417, 63323-0417-01, 63323-0417-10, 63323-0418, 63323-0418-01, 63323-0418-20 |
| Lot numbers | 6010157 |
| Expiration dates | 2017-01 |
Product
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Reason for recall
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
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-0819-2016. 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.