Meitheal vecuronium bromide recalled for missing warning label
Meitheal Pharmaceuticals is recalling about 121,800 vials of Vecuronium Bromide for Injection, 10 mg, because the labels lack a required warning or prescription legend. No injuries have been reported. The FDA classified this as a Class III recall, which means it is unlikely to cause serious harm.
From the FDA notice · Read the official notice ↗
What to do
- Check whether you have NDC 71288-744-11 with lot numbers T1P0213A, T1P0313A, T1P0412A, T1P0413A, T1P0512A, or T1P0513A.
- Set aside any affected vials and do not use them until you have guidance from the manufacturer.
- Contact Meitheal Pharmaceuticals or your supplier for instructions on returns or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-744-11
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 121,800 vials
- Illnesses reported
- None reported
- Manufactured in
- 8700 W Bryn Mawr Ave Ste 600s, Chicago, Illinois, United States
- Classification
- Class III
- Recall number
- D-0108-2027
In the FDA's words
- Description
- Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-744-11 Labeling: Label Lacks Warning or Rx Legend Lot# T1P0213A: Exp. 30-Apr-29 Lot# T1P0313A: Exp. 30-Apr-29 Lot# T1P0412A: Exp. 30-Sep-28 Lot# T1P0413A: Exp. 30-Apr-29 Lot# T1P0512A: Exp. 30-Sep-28 Lot# T1P0513A: Exp. 30-Apr-29 Distribution: US. Nationwide Affected quantity: 121,800 vials
- Hazard
- Labeling: Label Lacks Warning or Rx Legend
2 products in this recall
The agency lists each product separately. Check every one you might have.
- Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-744-11 (this page)D-0108-2027 · 121,800 vials
- Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21D-0109-2027 · 10,200 vials