Indian Manufacturer Issues Metoprolol Drug Recall for Dissolution Problems
Another Indian pharmaceutical manufacturer – this time, Dr. Reddy’s Laboratories Ltd – has issued a Metoprolol drug recall for 13,560 bottles of generic hypertension drug metoprolol succinate in the United States after the medication failed a dissolution test.
Metoprolol is the generic form of Toprol, manufactured by AstraZeneca. Recently, another Indian manufacturer, Wockhardt Ltd, also recalled their metoprolol pills. The company issued a drug recall for 109,744 bottles of metoprolol for the same dissolution problem.
The voluntary drug recall began on May 23rd, and was posted to the FDA’s website on Thursday, June 19th.
Tablet dissolution testing is important because it measures how well the drug releases into the body. Problems with dissolution can lead to not enough of the prescription in the patient’s body, or too much at once, which can increase the risk of serious side effects. A similar problem led the FDA to issue a drug recall for generic Wellbutrin after numerous complaints and studies showed that budeprion was ineffective because of dissolution problems.
In March of this year, Dr. Reddy also issued another voluntary drug recall for potential microbial contamination in its generic heartburn drug, lansoprazole.
FDA Visit to India Does Not Help Regulate Generic Drug Recall Problems
Amid rising concerns about the quality of generic drugs manufactured in India, FDA head Margaret A. Hamburg went to India in February to investigate generic drug manufacturers. Unfortunately, it appears her visit has done little to prevent drug recalls related to quality control mistakes from overseas manufacturers.
Several generic drug manufacturers in India have come under fire in recent years because of violations of FDA regulations. Manufacturers Ranbaxy Laboratories and Wockhardt Ltd were both banned from selling prescription generic drugs in the US after federal inspectors found the companies had retested drugs’ efficacy to gain favorable results.
In June 2013, the Supreme Court upheld a 2011 decision that generic drug manufacturers were not liable for personal injury caused by their products, because generic drug companies must legally have the same safety labels as their brand-name counterparts. If a patient ends up with a personal injury due to safety problems with a drug they have been prescribed, they can sue the brand name manufacturer, but they cannot sue the generic drug company for misinformation about safety. Brand name companies, also, are able to independently update their safety and warning information, while generic drug companies have had to wait until new information about the original drug was released.
“Now, with the generic industry having grown up, most people are taking generic drugs,” said Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, in a telephone interview. “It’s really time to level the playing field.”
The Strom Law Firm Can Help with Dangerous Drug Recall Cases
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using dangerous drugs, tainted dietary supplements, or medical devices that did not receive a proper drug recall, dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800