Meitheal Recalls Vecuronium Bromide Injection Due to Labeling Defect
Meitheal Pharmaceuticals is recalling Vecuronium Bromide for Injection because the label lacks a warning or Rx legend.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Class III due to a labeling defect where the label lacks a warning or Rx legend. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Meitheal Pharmaceuticals, Inc. is recalling Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton. The product is sterile and prescription-only. The recall involves 121,800 vials distributed nationwide in the United States.
The recall was initiated because the product label lacks a warning or Rx legend. This is a labeling defect identified by the U.S. Food and Drug Administration.
The affected lots are T1P0213A, T1P0313A, T1P0412A, T1P0413A, T1P0512A, and T1P0513A. The expiration dates for these lots are 30-Apr-29 and 30-Sep-28. Healthcare providers and pharmacies should stop using the affected product and return it to the manufacturer.
The recalled product
- Product
- VECURONIUM BROMIDE (VECURONIUM BROMIDE)
- Brand
- VECURONIUM BROMIDE
- Manufacturer
- Meitheal Pharmaceuticals, Inc
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 121,800
Distribution
Distributed nationwide across the United States.
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