Issue :

Saudi FDA issued Recall two batches of pms-AMITRIPTYLINE 50mg TABS due to presence of (N-nitrosodimethylamine (and (N-nitroso-nortriptyline ( impurities. Pharmascience Inc. is voluntarily recalling the affected batches.

Recommendations :

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

for patients

• Consult your healthcare provider prior to discontinuing use of the affected batches, or for any health concerns.
• 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).