Meitheal vecuronium bromide vials recalled over missing warning label
Meitheal Pharmaceuticals is recalling two lots of Vecuronium Bromide for Injection, 20mg, because the labels lack the required warning and prescription legend. The recall covers 10,200 single-dose vials sold nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether you have lots T1P0113C (exp. 28-Feb-29) or T1P0612C (exp. 31-Oct-28).
- Stop distributing or using affected vials and keep them separate until you hear from the manufacturer.
- Contact Meitheal Pharmaceuticals or your supplier for return or replacement instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 10,200 vials
- Illnesses reported
- None reported
- Manufactured in
- 8700 W Bryn Mawr Ave Ste 600s, Chicago, Illinois, United States
- Classification
- Class III
- Recall number
- D-0109-2027
In the FDA's words
- Description
- Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21 Labeling: Label Lacks Warning or Rx Legend Lot# T1P0113C: Exp. 28-Feb-29 Lot# T1P0612C: Exp. 31-Oct-28 Distribution: US. Nationwide Affected quantity: 10,200 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: 71288-744-11D-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: 71288-745-21 (this page)D-0109-2027 · 10,200 vials