Huons Co., Ltd.: Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Ko
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Huons Co., Ltd.
- 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)
- Reason / hazard
- Lack of Assurance of Sterility
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide.
- Recall initiated
- 2026-04-02
- Code info
- All lots within expiry
- Product quantity
- 33,599,925 ampules and 23658125 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Jecheon
- State
- N/A
- Country
- Korea (the Republic of)
- Event id
- 98724
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