Drug product
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)
D-0530-2026
Product summary
- Firm
- Huons Co., Ltd.
- Event
- Event 98724
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,260,170 ampules
- Official record key
drug-enforcement:D-0530-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry
Distribution pattern: USA Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility