Manufacturer Wockhardt Recalls Generic Toprol XL Tablets
Bloomberg reports that the Mumbai-based manufacturer, Wockhardt Ltd., is recalling 109,744 bottles of its generic version (metoprolol succinate) of the heart pill Toprol XL. The FDA is starting to crack-down on manufacturers in its efforts to monitor the safety and quality of generics.
According to an FDA report, the recall was issued as a result of failed dissolution tests. The investigation for a recall came after significant complaints were made against the drug for lack of effectiveness and reports of startling side effects from 3,425 adverse incident reports. Two of Wockhardt’s Indian facilities were placed on the import-alert list last year, one of which manufactures metoprolol, after FDA inspectors found that quality controls were not met and raw-material storage areas contained mold growth.
Meanwhile, the FDA is planning an extensive study of generic Toprol XL, which will expand on the existing $20 million testing program of generic drugs. It is speculated that the added research of metoprolol will begin as early as September.
The choice of a lawyer is an important decision and should not be based solely on advertisements.