Official recall notice
FDA DeviceClass INotable
FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN
- Recall date
- 2026-06-03
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Recommended action
What to do
28106 kits
Product description
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.