Wockhardt's regulatory quagmire has gotten stickier for a plant where regulators found evidence that some training records were falsified. The U.K. announced a "precautionary recall" today of 16 of the generic drugmaker's products after last week issuing an import ban against the targeted plant.
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) said the recall included drugs used to treat such conditions as high blood pressure, diabetes, epilepsy, depression and schizophrenia, among others. It said it found no evidence that the drugs created a risk for patients and that there was no need for patients to return their medications; "however, the MHRA has to act in the interests of public health as poor manufacturing standards cannot be allowed to continue." It said most of the drugs were also available from other manufacturers.
The regulatory agency placed a ban on products from Wockhardt's Waluj plant last week after an inspection found issues. It is the same plant that the FDA had placed a ban on in May. This week, the MHRA clarified that the U.K. ban prevents the drugmaker from exporting from that plant to any country in the EU. When the U.K. ban was first issued, Wockhardt disclosed it but did not indicate that it applied to all of Europe. In an emailed statement to FiercePharma Wednesday, the MHRA said: "The statement of non-compliance with Good Manufacturing Practice (GMP) guidelines means that Wockhardt have been stopped manufacturing medicines for Europe."
The U.K. regulator said that an inspection of the plant in March found a number of problems including the potential for a low risk of "cross-contamination." It also found "evidence of data falsification in relation to staff training records that were rewritten without authorization," the MHRA said.
The company told The Business Standard that the plant in question doesn't ship products to EU countries outside of the U.K. Workhardt is working to get the issues resolved, and the company has indicated it could shift some production to other plants to minimize the impact. But Wockhardt Chairman Habil Khorakiwala told the Indian press service PTI that the U.S. ban could cost the company $100 million in lost sales.
- here's the MHRA release
- read the Business Standard story