Recall batches of Apo-Amitriptyline 10 Mg and 25mg FCT

Recall batches of Apo-Amitriptyline 10 Mg and 25mg FCT

2024-10-31

Product Description :

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Apo-Amitriptyline 10 Mg FCT

Amitriptyline

Unregisted

RN6384

TA6008

TF8586

TW2842

Apotex Inc

Apo-Amitriptyline 25 mg FCT

TA6061

Issue :

Saudi FDA issued a recall of the mentioned batches of Apo-Amitriptyline 10 and 25mg Mg FCT due to the chemical impurities (Nitrosamines) exceeded the permissible limit. Apotex Inc is voluntarily recalling the affected batches

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 Saudi FDA 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).


Recall batches of Apo-Amitriptyline 10 Mg and 25mg FCT