Drug major Lupin Ltd. is recalling 46,700 bottles of Morphine Sulfate extended-release tablets—used to treat severe pain—in the U.S. market, according to a report by the U.S. Food and Drug Administration.
Lupin Somerset is recalling the drug in various strengths due to “failed impurities/degradation specifications”, the latest enforcement report by the U.S. FDA said.
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“Product was shipped to five wholesalers and one supermarket chain who may have further distributed the product throughout the U.S.,” it added.
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Zydus Pharmaceuticals USA Inc., a subsidiary of Zydus Cadila Ltd., is also recalling 7,668 bottles of Carvedilol Tablets, used to treat high blood pressure. The drugmaker is recalling the drug due to the “presence of foreign tablets/capsules”, U.S. FDA said.
“Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125 mg,” it added.
The U.S. FDA classified both the recalls as Class III.
A Class III recall by the U.S. FDA is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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