Cisatracurium Besylate Injection — Class I drug recall D-0286-2021
Terminated recall by Meitheal Pharmaceuticals Inc, reported 2021-03-03, distributed nationwide. Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials misl
| Recall number | D-0286-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meitheal Pharmaceuticals Inc, Chicago, IL, United States |
| Recall initiated | 2021-01-27 |
| Classified | 2021-02-22 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 34,860 vials |
| Reason classes | labeling |
| NDC | 71288-0712, 71288-0712-05, 71288-0712-06, 71288-0713, 71288-0713-20, 71288-0713-21, 71288-0714, 71288-0714-10, 71288-0714-11 |
| Lot numbers | C11507A |
Product
Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.
Reason for recall
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
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-0286-2021. 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.