Huons Co., Ltd.: FDA regulatory signals
This page aggregates the United States FDA regulatory records that reference Huons Co., Ltd. in the datasets indexed by this site. Across the ingested data, Huons Co., Ltd. is associated with 4 recall record(s), 0 drug-shortage record(s), and 0 approval record(s). The most recent dated event attributed to this firm in the indexed data is a recall record dated 2026-04-22. These counts are coverage-limited activity signals derived only from the specific FDA datasets indexed here. They are NOT quality ratings, reputational scores, or judgements about the firm or its products. A higher or lower count reflects how often a firm appears in these particular public records over the ingested window — nothing more. Recalls and shortages are routine parts of pharmaceutical regulation, and their presence here is an administrative fact, not an indication of wrongdoing or of product danger. Use this page as a finding aid to locate the underlying FDA records, then verify every detail against the official source. This page contains regulatory information only and offers no medical advice.
Signal summary
| Recall records | 4 |
|---|---|
| Shortage records | 0 |
| Approval records | 0 |
| Most recent record date | 2026-04-22 |
| Most recent record type | recall |
These counts are not a quality rating. They are coverage-limited activity signals showing how often this firm appears in the indexed FDA recall and shortage records over the ingested window. They are not reputational scores or judgements about the firm or its products.
Recall records
- 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. · Class II · 2026-04-22
- 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) · Class II · 2026-04-22
- 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) · Class II · 2026-04-22
- Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton) · Class II · 2026-04-22
Source limitations
This page is built only from the FDA recall and shortage records this site has ingested. It does not represent the firm's full regulatory history, its approvals, or any data held in sources not indexed here. The ingested window is finite and can lag the live FDA record, so counts and dates reflect a point in time. Every linked record points back to the verifiable official source; confirm details there. This page contains regulatory information only and offers no medical advice, no assessment of product safety, and no recommendation of any kind.
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages)
- Publication date
- Not available
- Ingested
- 2026-06-09
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.