This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1. Catalog Number: 400866. UDI Number: (01)10885403469497(17)270101(10)B01V232D. Lot Number (Expiration Date): B01V232D (2027-01-01). 2. Catalog Number: 405672. UDI Number: (01)00382904056728(17)270101(10)B03V267D. Lot Number (Expiration Date): B03V267D (2027-01-01). 3. Catalog Number: 405673. UDI Numbers: (01)00382904056735(17)261001(10)B01V225D, (01)00382904056735(17)270101(10)B01V281D, (01)00382904056735(17)261001(10)B02V211D, (01)00382904056735(17)261001(10)B02V217D. Lot Numbers (Expiration Date): B01V225D (2026-10-01), B01V281D (2027-01-01), B02V211D (2026-10-01), B02V217D (2026-10-01). 4. Catalog Number: 405674. UDI Number: (01)00382904056742(17)261001(10)B01V218D. Lot Number (Expiration Date): B01V218D (2026-10-01). 5. Catalog Number: 405675. UDI Numbers: (01)00382904056759(17)261001(10)B01V183D, (01)00382904056759(17)260901(10)B01V198D. Lot Numbers (Expiration Date): B01V183D (2026-10-01), B01V198D (2026-09-01). 6. Catalog Number: 405709. UDI Numbers: (01)00382904057091(17)261001(10)B02V202D, (01)00382904057091(17)260628(10)B02V174D. Lot Numbers (Expiration Date): B02V202D (2026-10-01), B02V174D (2026-06-28). 7. Catalog Number: 405721. UDI Number: (01)00382904057213(17)270101(10)B02V227D. Lot Number (Expiration Date): B02V227D (2027-01-01). 8. Catalog Number: 405723. UDI Number: (01)00382904057237(17)260628(10)B01V174D, (01)00382904057237(17)270101(10)B02V254D, (01)00382904057237(17)261001(10)B01V189D. Lot Numbers (Expiration Date): B01V174D (2026-06-28), B02V254D (2027-01-01), B01V189D (2026-10-01). 9. Catalog Number: 406704. UDI Number: (01)00382904067045(17)270101(10)B02V246D. Lot Number (Expiration Date): B02V246D (2027-01-01).
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.