More than 13,500 bottles of generic Toprol extended-release pills distributed by Dr. Reddy’s are being recalled due to concerns about the effectiveness of generic versions of the high blood pressure medication.
Last week, the FDA announced a Dr. Reddy’s generic Toprol XL recall after the manufacturer’s own tests confirmed that the pills may not dissolve properly.
While no illnesses or deaths have been associated with the recalled generic Toprol tablets, concerns about the effectiveness of the drugs have been raised by doctors for years, according to a report by the New York Times.
The recall affects 13,560 bottles of Metoprolol Succinate Extended Release Tablets, USP 25 mg, sold in 100-count bottles. Two lots of the drug were affected: Lot# C206578 with an expiration date of 05/14. and Lot# C207415 with an expiration date of 06/14.
Pills that do not dissolve properly may fail to deliver the proper dosage of drugs at the proper time, particularly extended release tablets, which are supposed to accurately dissolve over a long period of time, slowly releasing the medication into the body.
This is the second major generic Toprol recall in the last couple months. In May, the FDA announced that Wockhardt USA had sent out a letter in April announcing a Wockhardt generic Toprol XL recall, which affected 109,744 bottles for exactly the same problem.
That recall affected 30-count bottles of Metoprolol Succinate Extended-Release Tablets, USP 50 mg with lot numbers LN10686, LN10687, LN10688, LN10707, and LN10708. All had expiration dates of 02/15.
The recalls come in light of a pending FDA investigational study into the effectiveness of generic Toprol. The agency announced it would award grants for independent researchers to conduct the study following reports that generic Toprol XL was less effective and linked to more side effects than the AstraZeneca brand name drug.
All generic drugs are required to be bioequivalent to the brand-name products they imitate; meaning they should be just as effective and have the same risk of side effects. But since Marck 2009, the FDA has received more than 3,400 adverse event reports involving generic Toprol XL.
However, the reports do not identify which generic versions are causing the problems. The reports only state that the tablets are not AstraZeneca’s brand name version.
Wockhardt manufactured generic Toprol XL at a facility in Mumbai, India, that was banned from shipping drugs to the U.S. in November 2013, after the FDA found out that its workers were providing false information on quality control tests. The facility was also found to be unsanitary. Before the factory was banned from sending drugs to the U.S., it accounted for a quarter of all generic Toprol XL.
The recalled bottles appear to have been shipped to the U.S. before that ban took place. The ban did not include a recall of drugs Wockhardt had already imported to the U.S. from the Mumbai factory.
Novartis also used to manufacture the drug, but stopped following a massive recall in 2008 that affected about 6 million bottles. The recall was issued after the FDA declared that the drug did not meet the agency’s quality standards.