沙特 SFDA 通报 pdp-DIPHENHYDRAMINE 25mg 胶囊三批次自愿召回
Voluntary recall of Multiple Batches of Product: pdp-DIPHENHYDRAMINE 25mg Capsules
沙特 SFDA 通报 pdp-DIPHENHYDRAMINE 25mg 胶囊多批次自愿召回，原因为亚硝胺杂质 NDDH 超出可接受限度。受影响批号为 653544、651074、656693，生产商为加拿大 Pharmascience Inc，通报中注册号标注为未注册。召回在批发与医院层面进行，SFDA 要求医务人员立即停止发放、隔离全部剩余库存并退回供应商，患者停药前应先咨询医务人员。
通报列出三个受影响批号、批发与医院层面召回范围及 NDDH 超限原因，便于核对批次与库存处理。
Voluntary recall of Multiple Batches of Product: pdp-DIPHENHYDRAMINE 25mg Capsules
2026-10-21
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer pdp-DIPHENHYDRAMINE 25mg Cap DIPHENHYDRAMINE غير مسجل 653544 651074 656693 Pharmascience Inc-Canada
التصنيف
Health practitioners
التاريخ
2026-10-20
اسم المستحضر
pdp-DIPHENHYDRAMINE 25mg Cap
نوع المستحضر
Medicine Product
اجراء الاستدعاء
Wholesale level
مستوى الاستدعاء
Hospital level
سبب السحب
The Saudi Food and Drug Authority (SFDA) has issued a recall Multiple Batches of Product pdp DIPHENHYDRAMINE 25mg Cap due to exceeded the acceptable limit for the nitrosamine impurity (NDDH), which may affect the quality and safety of the product
التوصيات
For healthcare professionals: Stop dispensing the batch immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.
For patients,
Consult your healthcare provider prior to discontinuing use of the affected batch, or for any health concerns.
- Contact the recalling firm or SFDA if you have any questions about the recall.
- Adverse reactions or quality problems experienced with the use of this product may be reported to Saudi Vigilance either online or call center (Call 19999).
来源：Saudi SFDA 药品召回与质量通报 · sfda.gov.sa