Drug major Sun Pharmaceutical Industries Inc. (the US subsidiary of Sun Pharma), initiated a recall of antidepressant medication used to treat major depressive disorder and seasonal affective disorder.
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets), is supplied for oral administration as 150 mg, round white to off-white extended-release tablets.
An action basically taken to remove the particular product from the market can be done by either the company itself or by the FDA under its own statutory authority. In this case, it is a Voluntary recall initiated by the company itself.
The recall has been initiated in the US alone and has been classified as a Class III recall which means the exposure to this recalled product is not likely to cause adverse health consequences.
The products were distributed by Sun Pharmaceutical Industries, Inc. Cranbury, and manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat India.
The batches recalled have an expiry date of July, 2016. The recall has been initiated since 27-Jun-16.
Reason for Recall?
While not all details have been divulged by the company or the FDA, the simple reason stated is “Failed Dissolution Specifications: Dissolution is principally useful as a QC test. Dissolution testing is required for all solid oral Pharmacopeial dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect.”
Whenever a dissolution test fails to meet specifications, an investigation should be performed to determine the cause(s) of the failure. In this case, no information is available if the company performed a dissolution test post receipt of complaints as this was a voluntary recall and not an FDA driven.
We will wait for the company to issue a press release so as to identify the financial impact of this recall.
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