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| Wockhardt's headquarters in Mumbai, India--Courtesy of Wockhardt |
India's troubled Wockhardt is again expanding its voluntary recall of metoprolol succinate extended-release tablets, a generic of AstraZeneca's ($AZN) hypertension drug Toprol XR. This is Wockhardt's third recall of the drug in about four months.
This time, the drugmaker announced it would recall four lots of 200 mg dose pills, amounting to about 11,660 bottles. The recall was again for failing dissolution testing, this time at the four-hour time point, according to the FDA weekly Enforcement Report. The tablets were manufactured at a facility in Mumbai.
The FDA has been testing some generic drugs for equivalency as part of a $20 million program launched last year. One of those is metoprolol succinate, a drug that accounts for about 40 million prescriptions a year, 90% of which are generics of AstraZeneca's Toprol XL. Wockhardt is one of four producers of the product, along with Mylan ($MYL), Actavis ($ACT) and Dr. Reddy's Laboratories.
Wockhardt's manufacturing standards came into serious question last year as the FDA banned two of the plants from which it exports drugs to the U.S. FDA inspectors found that it had been manipulating its testing data and passing for sale drugs that were not up to specs. The agency has since followed up with an intensive review of Wockhardt's Morton Grove plant near Chicago, which was helping the drugmaker prop up its U.S. sales, citing it for many of the same kinds of problems.
The bans have had a huge impact on Wockhardt's earnings. The drugmaker reported earlier this month that its April-June net profit was 199.5 million rupees ($3.26 million), compared with 3.23 billion rupees ($52.9 million) a year earlier, off 94%. Net sales fell 27% to 9.91 billion rupees ($162 million) and were off 60% in the U.S.
- here's the recall