The FDA banned U.S. exports from Wockhardt's Waluj and Chikalthana
plants in central India in 2013, citing manufacturing quality
lapses.
The agency conducted an inspection of both plants earlier this year,
following which it made some "observations" regarding batches of
some drugs that were made at the plants when they were not banned,
Wockhardt said in a statement.
"Several batches" of products produced at the plants before the bans
were imposed "may still be" selling in the United States, the
company said.
While there is no evidence of risk to patient safety from those
drugs, Wockhardt said the recall was being conducted "as a measure
of preparedness and as an abundant precaution."
In February, Wockhardt said the FDA raised fresh concerns regarding
the manufacturing quality at the Waluj site.
The company's shares were down 5 percent at 1,261 rupees by 0430 GMT
on Tuesday, while the wider market was up 0.3 percent.
(Reporting by Zeba Siddiqui in Mumbai; Editing by Anand Basu)
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
![](../images/ads/current/Symphony_122313.png)
![](http://archives.lincolndailynews.com/2015/Apr/28/images/ads/current/business_directory_filler.png)
![](http://archives.lincolndailynews.com/2015/Apr/28/images/ads/current/tourism_lda_021315.png) |