Recall one batch of ZITOTEC 200mg

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الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

ZITOTEC 200mg

Misoprostol

Unregistered

GKC1864A

Sun Pharma Laboratories ITD. India


Issue :

Saudi FDA has issued a recall of one batch of ZITOTEC 200mg due to the batch did not comply with the necessary technical requirements.


Recommendations :

For healthcare professionals: Stop dispensing the above batch immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.

For patients,

  1. Consult your healthcare provider prior to discontinuing use of the affected batch , or for any health concerns.
  2. Contact the recalling firm or SFDA if you have any questions about the recall.
  3. 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).
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