Sun will recall 31,762 bottles of anti-depressant

This is a class III recall initiated voluntarily by Sun

Sun Pharmaceutical Industries is recalling 31,762 bottles of bupropion hydrochloride extended-release tablets in America, used for treatment of major depressive disorder, due to ‘failed dissolution specifications’.

That country's Food and Drug Administration (FDA) said in its latest Enforcement Report that this was a ‘Class III’ recall, initiated voluntarily by Sun. Such a recall is initiated where “use of or exposure to a violative product is not likely to cause adverse health consequences”.

Class I and II product recalls are far more serious, initiated when there is probability that use or exposure to the product in question can cause temporarily adverse or seriously adverse health consequences.

Drug absorption from a solid dosage depends on release of the drug substance from the product. Pharma companies carry out tests to check drug release characteristics and  assess overall product quality.

The tablets were made by Sun at its Halol (Gujarat) unit, alrady under an FDA scanner. After earlier inspections, it had served a warning letter to the company on Halol, last year.   The consequential remedial effort has impacted supplies and product approvals from the plant.

The US market contributes half the company’s consolidated revenue. Sun Pharma has since requested the FDA to re-inspect the Halol unit.

“Over  the past year, our cGMP (current good manufacturing pratices) capabilities have been strengthened significantly. Talent with long-standing global expertise has enhanced our abilities in this pertinent area. We are also targeting appropriate technology-based solutions to facilitate cGMP compliance, coupled with an increased focus on manpower training,” Sun Pharma managing director Dilip Shanghvi said in his letter to shareholders in the recent annual report. RECENT RECALLS

• Aurobindo Pharma recalled 23,016 bottles of Pantoprazole Sodium delayed-release tablets
• Cadila Healthcare: 2,626 bottles of Bupropion Hydrochloride extended-release tablets
• Sun Pharma: 12,109 bottles of Carvediol tablets
• Lupin: 3,192 bottles of Escitalopram and 26,436 bottles of Lisinopril tablets