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Lupin recalls 85,987 bottles of Lisinopril & Hydrochlorothiazide Tablets, second recall post EIR from USFDA

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Lupin Logo 2Drug major Lupin Pharmaceuticals Inc. (the US subsidiary of Lupin Pharmaceuticals), initiated a recall of Lisinopril & Hydrochlorothiazide Tables.

Lisinopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Lisinopril is used to treat high blood pressure (hypertension) or congestive heart failure. It is also used to improve survival after a heart attack.

Hydrochlorothiazide is used alone or in combination with other medications to treat high blood pressure. Hydrochlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids.

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?

  • Lisinopril Tablets, USP 30mg, packaged in 500 count bottles and 100-count bottles
  • Lisinopril Tables, USP 40 mg, 1000-count bottle
  • Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in 100-count bottles and 5000-count bottles

All these products have an expiry date of September, 2016

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

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.”

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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