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.
Reason for recall: 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. Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY. Quantity: 3,550 units Lot/code info: 1. Catalog Numbers: 400868. UDI Numbers: (01)10885403469510(17)261001(10)B01V206D, (01)10885403469510(17)261001(10)B01V220D, (01)10885403469510(17)270101(10)B02V266D. Lot Number (Expiration Date): B01V206D (2026-10-01), B01V220D (2026-10-01), B02V266D (2027-01-01). 2. Catalog Number: 405652. UDI Numbers: (01)00382904056520(17)270130(10)B01V353D, (01)00382904056520(17)270101(10)B02V267D. Lot Numbers (Expiration Date): B01V353D (2027-01-30), B02V267D (2027-01-01).
10885403469510, 00382904056520
Official record: FDA (Device enforcement) ↗
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