The loratadine and pseudoephedrine sulphate extended release
tablets being recalled carry an expiry date of September 2015,
and were manufactured by Ranbaxy's Ohm Labs plant in New Jersey,
which is the company's only facility making generics for the
United States. (http://r.reuters.com/nuk98v)
All other Ranbaxy plants, based in India, have been banned from
exporting generics to the United States after the FDA found
manufacturing quality glitches that the agency believed could
compromise the quality of medicines.
Rival Indian drugmaker Sun Pharmaceutical Industries Ltd agreed
to buy Ranbaxy last month in a $3.2 billion deal, betting it can
fix Ranbaxy's problems.
The FDA classified the recall by Ohm Labs as Class II, which
means use of or exposure to the recalled products may cause
temporary or medically reversible adverse health consequences.
Ranbaxy did not immediately respond to requests for comment.
(Reporting by Zeba Siddiqui in Mumbai;
editing by Subhranshu
Sahu)
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