D-0286-2021 Class I Terminated
FDA drug recall D-0286-2021 was initiated by Meitheal Pharmaceuticals Inc on Jan 27, 2021 and is designated Class I. 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… The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 34,860 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 3, 2021
- Initiation Date
- Jan 27, 2021
- Termination Date
- Oct 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,860 vials
Product Description
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
Distribution Pattern
Nationwide USA
Code Information
Lot C11507A
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0286-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026