Drug product
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
D-0529-2026
Product summary
- Firm
- Huons Co., Ltd.
- Event
- Event 98724
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33,599,925 ampules and 23658125 vials
- Official record key
drug-enforcement:D-0529-2026
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