India's Wockhardt has voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, calling the state of its plans to recover from U.S. FDA import bans on two plants into further question, Business Line said.
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| Wockhardt chairman Habil Khorakiwala |
Wockhardt Chairman Habil Khorakiwala said in April that the company had voluntarily withdrawn 12 to 15 drugs from the U.S. manufactured at its two facilities in Aurangabad, India--Chikalthana and Waluj.
In May, the company said it had also withdrawn blood pressure drug captopril and antibiotic clarithromycin tablets as a precautionary move, but what the FDA said was based on in good manufacturing practices.
Now the third such recall in as many months sees U.S.-based pharma company Allegiant Health recalling the tablets from the U.S. market that were made by made by Wockhardt in India. The recall was based on a failure to adequately investigate customer complaints, Business Line said, citing an FDA Enforcement Report.
Earlier this month, the issue of drug manufacturing woes in India continued in the spotlight with Sun Pharmaceutical, India's top drug company, saying it will focus on one plant at a time to restore the fortunes of four Ranbaxy manufacturing units banned by the U.S. FDA.
Ranbaxy's units Mohali and Toansa in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh are currently barred from exporting drugs to the U.S.
- here's the story from The Hindu Business Line