India’s Wockhardt to recall some drugs made in India after U.S. FDA concerns
(Reuters) – Indian generic drugmaker Wockhardt Ltd said on Tuesday it would recall some drugs manufactured at its two plants in India before the U.S. Food and Drug Administration (FDA) banned those sites due to quality concerns.
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)
Source: Reuters Health