The US arm of Sun Pharmaceutical Industries is recalling over 2,500 bottles of Metformin hydrochloride extended release tablets from Arizona on account of presence of foreign substance in one lot. United States Food and Drug Administration (USFDA) said the company is recalling 2,508 bottles of Metformin hydrochloride extended release tablets 500 mg, packaged in a 500-count bottle.

The reason for recall is presence of foreign substance—one lot of these tablets contains foreign matter identified as a piece of rubber glove detected in one tablet, it added. The tablets were manufactured at Sun Pharma’s Halol facility, USFDA said in its Enforcement report.

For Sun Pharma, this product recall is not first time. Last year also, news Published on Nov, 25, 2017, that Indian drug major Sun Pharma’s subsidiary in the US is voluntarily recalling two lots of its diabetes drug ‘Riomet’ due to microbial contamination. This is one of several voluntary recalls that the firm has carried out for different products, according to reports by the US Food and Drug Administration (US FDA).

Similarly, any other Pharma companies may be required to go for unexpected product recall which is prohibitive/ expensive.

What is Product Recall –

A product recall is a request from a manufacturer to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller at risk of legal action.

Product Recall Insurance –

Product recall insurance covers expenses & losses resulting from a product recall. Product recall is generally classified as either first-party losses or third-party losses.

First Party recall covers – direct expenses such as

• Notification of customers
• Shipping costs
• Warehouse and storage expense
• Cost to dispose of products
• Cost of extra personnel required to conduct the recall

Third Party recall cover –

• Recall expenses of the third party for the recall of any product that uses your product
• Business Interruption (lost income and expenses) of third parties using your product
• Cost to repair and rehabilitate third party’s reputation
• Additional cost to purchase substitute products to replace your products

Why to purchase product recall –

• Product recall events happen almost every day.
• Governmental oversight is stronger than ever.
• The costs for a recall are prohibitive/ expensive.
• Product Recall cover can be customized to fit the client’s needs.

** This is a summary document based on R&D done by Beacon Insurance Brokers Pvt Ltd. Broker accepts no liability for any loss arising directly or indirectly for any error or omission in this document.  **