Recall of batch No. 1407169 of the product: Xeractan 20 mg

Recall of batch No. 1407169 of the product: Xeractan 20 mg

2026-04-16

Product Description :

 

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Xeractan 20 mg soft gelatin capsule

Isotretinoin

2805257489

1407169

GAP SA PHARMACEUTICAL

Issue :

The Saudi Food and Drug Authority (SFDA) has issued a recall of batch No. 1407169 of the product Xeractan 20 mg soft gelatin capsules due to out-of-specification results observed during stability studies, which may impact the product’s quality and safety.

Recommendations :

For healthcare professionals: Stop dispensing the 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).


Recall of batch No. 1407169 of the product: Xeractan 20 mg