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Lupin recalls 54,472 vials of Ceftriaxone, first recall post receipt of EIR from USFDA

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Lupin Logo 2Drug major Lupin Pharmaceuticals Inc. (the US subsidiary of Lupin Pharmaceuticals), initiated a recall of Ceftriaxone Sodium (Sterile) vials and the API (active pharmaceutical ingredient as well.

While we wait for the company to come out with their press release regarding this (none issued when this post went live) we decided to dissect this ourselves. Though we do not know the financial impact of this recall on the firm’s revenue, the stock market impact of this recall and its earlier FDA inspection impact can clearly be seen in the stock’s price which is still trading closer to its quarterly low.

Lupin is not the only firm that has had to initiate a recall of its products. Data from the US FDA shows that a total of 3300 recalls have been initiated since the start of 2016 with 19 (including 5 of Lupin) coming from products manufactured out of Indian Pharma facilities.

Other earlier recalls (as per the FDA database) include Dr. Reddy’s (for its own Bachuppally manufacturing facility and outsourced manufacturing to Gland Pharma), Heritage International, Macleods Pharma USA (from its own Baddi, Himachal Pradesh facility), PD-Rx Pharmaceuticals (from outsourced manufacturing to Wockhardt, Mumbai), Sandoz Inc (from outsourced manufacturing to Mylan Laboratories, Hyderabad), Shakti Group USA (from outsourced manufacturing to Laljee Godhoo & Co., Mumbai), Sun Pharma Global (from manufacturing at Halol, Gujarat), Torrent Pharmaceuticals (from manufacturing at Mehsana, Gujarat), Zydus Pharmaceuticals USA (from its own Cadila Healthcare, Ahmedabad facility).

Back to Lupin now. The recall – 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 2 specific regions alone – the whole of United States and Puerto Rico and it has been classified as a Class III recall which means the exposure to this recalled product is not likely to cause adverse health consequences.

Products Recalled?

Though the product is a single one but are present in multiple forms i.e. different milligrams and hence has had to list them as different/ multiple recalls i.e. (1) 15,408 vials of Ceftriaxone for Injection USP, 250 mg; (2) 7,908 vials of Ceftriaxone for Injection USP, 500 mg; (3) 30,586 vials of Ceftriaxone for Injection USP, 1 g; (4) 570 vials of Ceftriaxone for Injection USP, 2 g; along with (5) 741.171 kg of Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient.

What is Ceftriaxone Sodium?

Ceftriaxone is often used to treat infections of the lung, urinary tract, skin, abdomen, bone, joint, and lining of the brain, depending on the bacteria causing them. It can also be used to treat gonorrhoea (a sexually transmitted infection). It is used to prevent or treat certain infections caused by bacteria. It is given by injection only into a muscle or vein. (Source)

Reason for Recall?

While not all details have been divulged by the company or the FDA, the simple reason stated is “CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.”

In simple words – the active pharmaceutical ingredient or API manufactured at its Mandideep factory (Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046), the same facility which was slapped with a Form 483 (read about this here) failed intermediates failed specifications.

This was the first observation (read about this here)  noted by the FDA inspectors in the form 483. The inspection mentions that “rejected lots of intermediaries were used for the production of sterile API without being included as part of the standard manufacturing process. The APIs that used these rejected intermediates were made into the finished drugs and commercially distributed from 2012 to 2015.”

The company confirmed this by saying that the observation related to 1 sterile product which did not impact the end product. This sterile product now happens to be Ceftriaxone Sodium (Sterile).

We will wait to see what the company has to add on to this recall. Do note that the company has received an all ok from the US FDA in the form of EIR for both its Mandideep and Aurangabad facilities.

Holdings: Analyst and family do own stock listed above. Please assume we are biased.

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