When India's Wockhardt acknowledged recently it was pulling all of the drugs still on the market that it had shipped before the FDA banned two of its plants, it didn't say what those numbers might add up to. Try more than 7.2 million bottles, cartons, pouches and drums amounting to hundreds of millions of tablets and capsules.
Wockhardt Chairman Habil Khorakiwala
The drugmaker has had a few recalls amounting to tens of thousands of units since it first declared it intentions but now in a sweeping effort to clear the market, it has issued 35 recalls of about 20 different drugs that add up to the tens of millions of units. It includes products like blood pressure meds amlodipine besylate and lisinopril and antiseizure drug phenytoin sodium; a generic of the sleep aid Ambien; and the antibiotic azithromycin. It includes different dosages of many of the drugs.
When Wockhardt announced its intentions in April, it said that while there was no evidence of risk, that it was pulling the products out of "abundant precaution" as part of its remediation plan for its facilities in Waluj and Chikalthana. The FDA Enforcement Report says the reason for the recalls was because Wockhardt had not adequately investigated consumer complaints.
But its failure to investigate customer complaints was only one of the many shortcomings the FDA documented at the plants. There were questions about the validity of drug testing and evidence that employees had destroyed testing records. There were also issues with sanitation. The bans of the plants in 2013 have devastated Wockhardt finances. The U.S. was the company's most profitable market and accounted for nearly half of its revenues before the FDA put a stop to their imports. By fiscal 2015, which closed out March 31, that was down to 27% and only 21% for the final quarter.
Wockhardt Chairman Habil Khorakiwala has tried to assuage investors' concerns several times, insisting that its remediation plans have been laid out for the FDA and that it has gotten positive feedback in a number of areas. He has told them Wockhardt have them shipping to the U.S. again next year.
But winning back FDA's confidence can be a long and costly endeavor. India's Ranbaxy Laboratories has four plants sidelined by the FDA for sales in the U.S. and two of those were put on the undeliverables list 7 years ago. Dilip Shanghvi, whose Sun Pharmaceutical bought Ranbaxy this year, has pledged to restore regulators' confidence in the facilities, but also acknowledged it may take a while and will squeeze Sun's profits in the process.