Cisatracurium Besylate Injection Recalled Due to Labeling Error
Meitheal Pharmaceuticals is recalling 34,860 vials of Cisatracurium Besylate Injection because cartons were mislabeled as Phenylephrine Hydrochloride.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which is defined as a situation where use of or exposure to a violative product may cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Meitheal Pharmaceuticals Inc. is recalling 34,860 vials of Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05). The product is packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06) and is available by prescription only. The recall is limited to Lot C11507A.
The recall was initiated due to a labeling error where cartons of Cisatracurium Besylate Injection were observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP. The vials were confirmed to contain Cisatracurium Besylate, but the incorrect labeling presents a significant risk of medication error.
The affected product was distributed nationwide in the United States. Healthcare providers and patients should check their inventory for this specific lot number and NDC. If the product is found, it should be discontinued and returned to the manufacturer or a qualified reverse distributor. Patients should not use the product if they have any questions regarding the labeling.
The recalled product
- Product
- CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
- Brand
- CISATRACURIUM BESYLATE
- Manufacturer
- Meitheal Pharmaceuticals Inc
- Category
- Drug — Prescription Injection
- Affected units
- 34,860
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot C11507A
Distribution
Distributed nationwide across the United States.
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