CLASS I Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Cisatracurium Besylate Injection, USP, 10mg recalled
Meitheal Pharmaceuticals is recalling Cisatracurium Besylate Injection, USP, 10mg per (2 mg per mL), Single-Dose Vial (, distributed nationwide in the US. The recall was initiated on 27 Jan 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0286-2021
- FDA event ID
- 87224
- Recalling firm
- Meitheal Pharmaceuticals, Chicago, IL
- Manufacturer
- Meitheal Pharmaceuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Jan 2021
- FDA classified
- 22 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Jan 2021 | Recall initiated by company | |
| 22 Feb 2021 | Classified by FDA | +26 days |
| 3 Mar 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot C11507A
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Meitheal Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cetrorelix Acetate for Injection , 0.25 mg per vial, Single-Dose Kit recalled | Meitheal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 4mg per Multi-Dose Vials recalled | Meitheal Pharmaceuticals | Potency & Assay | Nationwide |
Other Cisatracurium recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Cisatracurium Besylate Injection, 20 mg per (2 mg per mL) recalledCisatracurium | Fresenius Kabi USA | Labeling Errors | Nationwide |