India's Wockhardt recently disclosed that the FDA was not happy that it had continued to sell in the U.S. products that it had manufactured at two plants before the agency banned them. As a result, the Indian drugmaker said it was going to have to recall anything left in the U.S. made at those facilities. That burden has fallen in part to American Health Packaging, a subsidiary of AmerisourceBergen ($ABC), which has issued more than a dozen recalls of 6 products in different doses.
According to the most recent FDA Enforcement report, American Health Packaging is recalling thousands of cartons of tablets of amlodipine besylate, azithromycin, clarithromycin, famotidine and lisinopril as well as zonisamide capsules. All were manufactured by Wockhardt and all are being recalled because the company had not adequately investigated customer complaints, according to the notices.
The FDA banned Wockhardt's plants in Waluj and Chikalthana in 2013 after discovering, among other problems, that employees there had been manipulating data to indicate that batches that had failed testing had instead met specifications, then selling those in the U.S. Inspectors also found that employees had been deleting test data from computers that showed the batches were not up to par.
|Wockhardt Managing Director Murtaza Khorakiwala|
Wockhardt Managing Director Murtaza Khorakiwala has indicated that the company is making progress in improving the plants and that the FDA was impressed with its efforts "to bring about a culture change and to build a robust quality management." But the FDA was apparently not impressed that those culture changes had not include a decision to pull from the market anything that might be suspect even though it was made before the bans were put into place.
Wockhardt is among a growing list of Indian drugmakers that have fallen out of favor with the FDA over their manufacturing and testing issues. Just this week, an import alert was issued against India's Emcure Pharmaceuticals plant in Hinjawadi.
- access the recalls here