Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recall

Lack of Assurance of Sterility

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)

Quantity: 3,260,170 ampules

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Huons Co., Ltd., Jecheon, N/A

Date

Wednesday, April 22

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
USA Nationwide.

Status

Ongoing

Recall number

D-0530-2026

Source

U.S. Food and Drug Administration