80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration
Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures.
A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health.
Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea.
According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs.
Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications.
In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation.
Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated.
|
No. |
Marketing Authorization Holder |
Approval Number |
|
1 |
Shijiazhuang Lesheng Pharmaceutical Co., Ltd. |
SFDA H13023949 |
|
2 |
Jiangzhong Pharmaceutical Co., Ltd. |
SFDA H36022316 |
|
3 |
Shijiazhuang Fourth Pharmaceutical Co., Ltd. |
SFDA H13023932 |
|
4 |
Shijiazhuang Grey Pharmaceutical Co., Ltd. |
SFDA H13023934 |
|
5 |
Handan Bailin Pharmaceutical Co., Ltd. |
SFDA H13023945 |
|
6 |
Hebei Yongfeng Pharmaceutical Co., Ltd. |
SFDA H13023943 |
|
7 |
China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. |
SFDA H42022497 |
|
8 |
Jiangsu Enhua Pharmaceutical Co., Ltd. |
SFDA H32025932 |
|
9 |
Jiangxi Hongshuo Pharmaceutical Co., Ltd. |
SFDA H36022013 |
|
10 |
Jiangxi Hongshuo Pharmaceutical Co., Ltd. |
SFDA H36022244 |
|
11 |
Jiangsu Chenpai Pharmaceutical Group Co., Ltd. |
SFDA H32025935 |
|
12 |
North China Pharmaceutical Hebei Huanuo Co., Ltd. |
SFDA H13024102 |
|
13 |
North China Pharmaceutical Hebei Huanuo Co., Ltd. |
SFDA H13024073 |
|
14 |
Hebei Hengli Group Pharmaceutical Co., Ltd. |
SFDA H13024253 |
|
15 |
Hebei Tianzhi Pharmaceutical Co., Ltd. |
SFDA H13024245 |
|
16 |
Hebei Dongfeng Pharmaceutical Co., Ltd. |
SFDA H13024170 |
|
17 |
Hebei Jinzhuan Pharmaceutical Co., Ltd. |
SFDA H13024269 |
|
18 |
Tianjin Baihai Pharmaceutical Co., Ltd. |
SFDA H12021099 |
|
19 |
Henan Daxin Pharmaceutical Co., Ltd. |
SFDA H41024876 |
|
20 |
Henan Daxin Pharmaceutical Co., Ltd. |
SFDA H41025013 |
|
21 |
Shanxi Xinxing Pharmaceutical Co., Ltd. |
SFDA H14023068 |
|
22 |
Jiangxi Jiminke Pharmaceutical Co., Ltd. |
SFDA H36022305 |
|
23 |
Suzhou Hongsun Pharmaceutical Co., Ltd. |
SFDA H32025897 |
|
24 |
Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. |
SFDA H32026256 |
|
25 |
Guangxi Tiantianle Pharmaceutical Co., Ltd. |
SFDA H45021319 |
|
26 |
Tianjin Central Pharmaceutical Co., Ltd. |
SFDA H12021120 |
|
27 |
Tianjin Central Pharmaceutical Co., Ltd. |
SFDA H12021117 |
|
28 |
Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. |
SFDA H41024989 |
|
29 |
Tianjin Pacific Pharmaceutical Co., Ltd. |
SFDA H12021100 |
|
30 |
Hebei Guojin Pharmaceutical Co., Ltd. |
SFDA H13023940 |
|
31 |
Hebei Kaiwei Pharmaceutical Co., Ltd. |
SFDA H13023920 |
|
32 |
Hebei Sanshi Pharmaceutical Co., Ltd. |
SFDA H13023928 |
|
33 |
Yuanda Pharmaceutical (China) Co., Ltd. |
SFDA H42022649 |
|
34 |
Shanxi Tongda Pharmaceutical Co., Ltd. |
SFDA H14023309 |
|
35 |
Shanxi Guorun Pharmaceutical Co., Ltd. |
SFDA H14023402 |
|
36 |
Shanxi Fenhe Pharmaceutical Co., Ltd. |
SFDA H14023200 |
|
37 |
Shanxi Wanhui Pharmaceutical Co., Ltd. |
SFDA H14023333 |
|
38 |
Jilin Wantong Pharmaceutical Co., Ltd. |
SFDA H22025288 |
|
39 |
Changchun Overseas Pharmaceutical Group Co., Ltd. |
SFDA H22026726 |
|
40 |
Shijiazhuang Xiehe Pharmaceutical Co., Ltd. |
SFDA H13024084 |
|
41 |
Shandong Xinyi Pharmaceutical Co., Ltd. |
SFDA H37023541 |
|
42 |
Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. |
SFDA H13023979 |
|
43 |
Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. |
SFDA H13024261 |
|
44 |
Shandong Xinhua Pharmaceutical Co., Ltd. |
SFDA H37023523 |
|
45 |
Hebei Yuzhilin Pharmaceutical Co., Ltd. |
SFDA H13024426 |
|
46 |
Xinhai Yansheng Pharmaceutical Co., Ltd. |
SFDA H41024907 |
|
47 |
Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. |
SFDA H37023543 |
|
48 |
Dingfukang Pharmaceutical Co., Ltd. |
SFDA H41025139 |
|
49 |
Dingfukang Pharmaceutical Co., Ltd. |
SFDA H41025174 |
|
50 |
Changchun Changqing Pharmaceutical Group Co., Ltd. |
SFDA H22025234 |
|
51 |
Henan Baiquan Pharmaceutical Co., Ltd. |
SFDA H41024840 |
|
52 |
Changzhou Kangpu Pharmaceutical Co., Ltd. |
SFDA H32025910 |
|
53 |
Henan Baiquan Pharmaceutical Co., Ltd. |
SFDA H41025575 |
|
54 |
Lepu Hengjiuyuan Pharmaceutical Co., Ltd. |
SFDA H41024862 |
|
55 |
Hebei Ruicen Pharmaceutical Co., Ltd. |
SFDA H13023953 |
|
56 |
Hainan Xiansheng Pharmaceutical Co., Ltd. |
SFDA H46020588 |
|
57 |
Hainan Xiansheng Pharmaceutical Co., Ltd. |
SFDA H46020604 |
|
58 |
Yaodu Pharmaceutical Group Co., Ltd. |
SFDA H13023951 |
|
59 |
Shandong Xinyi Pharmaceutical Co., Ltd. |
SFDA H37023939 |
|
60 |
Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. |
SFDA H13023952 |
|
61 |
Tianfang Pharmaceutical Co., Ltd. |
SFDA H41024887 |
|
62 |
Lepu Hengjiuyuan Pharmaceutical Co., Ltd. |
SFDA H41025576 |
|
63 |
Zhejiang Huisong Pharmaceutical Co., Ltd. |
SFDA H33022412 |
|
64 |
Zhejiang Huisong Pharmaceutical Co., Ltd. |
SFDA H33022411 |
|
65 |
Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. |
SFDA H41024834 |
|
66 |
Henan Xueyinghua Pharmaceutical Co., Ltd. |
SFDA H41024896 |
|
67 |
Henan Xueyinghua Pharmaceutical Co., Ltd. |
SFDA H41025009 |
|
68 |
Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
SFDA H13023994 |
|
69 |
Handan Furong Pharmaceutical Co., Ltd. |
SFDA H13024077 |
|
70 |
Hebei Tiancheng Pharmaceutical Co., Ltd. |
SFDA H13024056 |
|
71 |
Hebei Kangtai Pharmaceutical Co., Ltd. |
SFDA H13024041 |
|
72 |
Guangdong Bidi Pharmaceutical Co., Ltd. |
SFDA H44025328 |
|
73 |
Guangdong Bidi Pharmaceutical Co., Ltd. |
SFDA H44024963 |
|
74 |
Zhengzhou Furuitang Pharmaceutical Co., Ltd. |
SFDA H41025579 |
|
75 |
Chongqing Kerui Pharmaceutical (Group) Co., Ltd. |
SFDA H50021730 |
|
76 |
Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. |
SFDA H41024872 |
|
77 |
Xinxiang Changle Pharmaceutical Co., Ltd. |
SFDA H41024895 |
|
78 |
Xinxiang Changle Pharmaceutical Co., Ltd. |
SFDA H41025012 |
|
79 |
Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. |
SFDA H41025008 |
|
80 |
Tianfang Pharmaceutical Co., Ltd. |
SFDA H41025010 |
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