UPDATE 2-EU plans recall of Indian-made generic Plavix

* Recall affects Acino product made at Indian factory

* EU drugs agency finds manufacturing failure at site

* EMEA doesn't expect shortage due to alternative supplies (Adds agency comment on alternative supplies, paragraph 5)

By Ben Hirschler

LONDON, March 25 (Reuters) - The European Medicines Agency has recommended the recall of all batches of generic Plavix from Swiss drugmaker Acino (ACIN.S) made at a factory in India, due to quality concerns about the heart drug.

Plavix, or clopidogrel, is sold as a brand by Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb (BMY.N). It is the world's second biggest selling medicine, with worldwide sales of more than $9 billion a year.

However, the medicine is off patent in some European markets, where Acino is among the companies that have been supplying a cheaper generic version.

Europe's drugs watchdog said on Thursday it was taking the action because of good manufacturing practice (GMP) failure at a factory in Visakhapatnam, India, where the active substance for the affected Acino product is produced.

It added there were other clopidogrel-containing medicines, both branded and generic, available in the European Union to ensure adequate supply. Acino has now changed its supplier and future batches will be made at a site that is GMP compliant.

While there have been no reports raising concerns from patients, pharmacists or prescribers, agency experts decided a recall was the appropriate precautionary measure.

Its recommendation that clopidogrel made at the Glochem Visakhapatnam factory be removed from the supply chain, starting at the level of pharmacists, has now been forwarded to the European Commission for the adoption of a legally binding decision.

The recall will cover eight clopidogrel-containing medicines for which Acino is the licence-holder, some of which are marketed by other generic drug companies.

The products are Clopidogrel A1 Pharma, Clopidogrel Acino, Clopidogrel Acino Pharma, Clopidogrel Acino Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz, the agency said.

Hexal and Sandoz are units of Novartis (NOVN.VX), while Ratiopharm is an unlisted German drugmaker that was sold last week to Israeli generic drugs group Teva (TEVA.TA). [ID:nLDE62H25F]

Acino was not immediately available to comment.

Plavix is used widely in treating heart attack patients. It works in a similar way to aspirin by stopping platelets -- tiny blood cells vital for the normal clotting process -- from clumping together and forming life-threatening clots. (Editing by Karen Foster, Gary Hill)