一般的名称: ホンノー錠 販売名 : ホンノー錠5×42包
Honnō Tablet 5×42-pack Recall Summary Honnō Tablet 5×42-pack, a medication used to reduce swelling and inflammation from bruises, fractures, and sprains, is being recalled by Honnō Pharmaceutical Co., Ltd. due to a calculation error in extract content testing during manufacturing that resulted in levels exceeding approved specifications across multiple lot numbers shipped between October 2019 and May 2026. No serious health problems have been reported to date, and the company states the amount of deviation from approved levels is minimal with no expectation of significant health risks.
- Recalling firm
- 製造販売業者の名称 : ホンノー薬品株式会社 製造販売業者の所在地: 山口県岩国市岩国1‐13‐12 許可の種類 : 第二種医薬品製造販売業 許可番号 : 35A2X00009
- Product
- Lot: ホンノー錠5×42包 LOT 数量 出荷日 AX02 75 2019/10/15 AX04 150 2019/11/5-19 AX05 150 2019/12/23-2020/1/29 B201 150 2020/2/24-3/17 B203 150 2020/5/9-11 B501 150 2020/5/24-6/7 B502 150 2020/7/1-9/2 B905 150 2020/10/28-11/19 BX01 75 2020/12/3 BX02 75 2021/2/15 C204 150 2021/3/8-4/1 C301 75 2021/5/10 C302 300 2021/5/17-6/22 C607 150 2021/8/2-18 C703 225 2021/9/6-10/25 CX04 150 2021/11/5-12/16 CY01 150 2022/1/11-2/3 CY03 75 2022/3/14 D203 75 2022/4/7 D204 75 2022/5/7 D301 75 2022/5/19 D302 225 2022/6/6-7/7 D604 75 2022/9/5 D605 150 2022/10/18-11/3 D702 75 2022/12/6 DY02 150 2022/12/20-2023/1/12 DY03 75...
- Reason
- 医薬品製造時のエキス含量試験の計算に誤りが確認された。再計算したところ、承認書規格を超えたため回収す る。
- Classification
- Class II
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Recall date
- 2026-06-26
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/60c87387-d59d-44a5-b5f8-43823aae758e