- Recalling firm
- Medline Industries, LP
- Reason for recall
- The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
- Affected products (lot / model / serial)
- 1) DYNJ0621189X, UDI-DI: 10195327638566(each), 40195327638567(case), Lot Number: 25ILA890; 2) PAIN1470A, UDI-DI: 10193489957365(each), 40193489957366(case), Lot Number: 25JLA514; 3) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25JDB583; 4) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDA180; 5) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDB274
- Units affected
- 333 kits
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2537-2026
- Recall initiated
- May 21, 2026
- FDA classification date
- June 29, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99162
- Last updated on HTM Vibe
- July 23, 2026