Food, drugs, devices › Meitheal Pharmaceuticals Inc
Drug recall: Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x
Meitheal Pharmaceuticals Inc (Chicago, IL) initiated this drug recall on 27 Jan 2021; FDA lists 1 product record under event 87224, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 19% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 16 Oct 2023. Initiation: voluntary: firm initiated. Meitheal Pharmaceuticals Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Meitheal Pharmaceuticals Inc, Chicago, IL.
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"
Distribution
"Nationwide USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0286-2021 | 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. | 34,860 vials | Class I | Terminated | 3 Mar 2021 |
Context
Other enforcement events for Meitheal Pharmaceuticals Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Feb 2026 | Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, | Drug | Class II | 1 |
| 3 Sep 2021 | Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, | Drug | Class III | 1 |
All 3 events for Meitheal Pharmaceuticals Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.