Who wrote this article?

Aakash Agarwal, Capitalmind's research team.

What does the "Products Recalled?" section say?

43,536 90-count bottles of 2.5mg 11,812 1000-count bottles of 10mg.

Lupin Goa Recalls 55,348 Bottles of Tablets Used For The Treatment of High Blood Pressure & Chest Pain

14 Sept 2016Aakash Agarwal2 min read

Quick Facts

What is "Lupin Goa Recalls 55,348 Bottles of Tablets Used For The Treatment of High Blood Pressure & Chest Pain" about?
What category is this article in?: Stocks
Who wrote this article?: Aakash Agarwal, Capitalmind's research team.
When was this article published?: Published 14 September 2016.
How long does this article take to read?: 2 min read
What topics does this article cover?: FDA, Pharmaceuticals, USFDA
What does the "The recall" section say?: 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.
What does the "Products Recalled?" section say?: 43,536 90-count bottles of 2.5mg 11,812 1000-count bottles of 10mg.
What does the "Reason for Recall?" section say?: 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 one of the form 483s for the Goa facility.
What does the "Disclaimer" section say?: Nothing in this newsletter is financial advice and should not be construed as such. Please do not take trading decisions based solely on the matter above; if you do, it is entirely at your own risk without any liability to Capital Mind. This is educational or informational matter only, and is provided as an opinion. Disclosure: The authors at Capital Mind have positions in the market and some of them may support or contradict the material given above, or may involve a direction derived from independent analysis.

Drug major Lupin Limited has initiated a recall of 55,348 bottles of **Amlodipine Besylate Tablets. **This recall has been initiated for the manufacturing done at the Verna facility in Goa which had earlier received multiple form 483s.

The products were manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland and the recall has been for batches sold in the US and that No recalled product was distributed to any foreign consignees by Lupin.

Amlodipine besylate tablets are a type of medicines known as a calcium channel blocker (CCB). They are used to treat high blood pressure (hypertension) and a type of chest pain called angina. They can be used by itself or with other medicines to treat these conditions

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?

43,536 90-count bottles of 2.5mg
11,812 1000-count bottles of 10mg.

All the 13 lots recalled have a product expiry date of April, 2016

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 one of the form 483s for the Goa facility.

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

Disclaimer

Nothing in this newsletter is financial advice and should not be construed as such. Please do not take trading decisions based solely on the matter above; if you do, it is entirely at your own risk without any liability to Capital Mind. This is educational or informational matter only, and is provided as an opinion.

Disclosure: The authors at Capital Mind have positions in the market and some of them may support or contradict the material given above, or may involve a direction derived from independent analysis.