New Delhi: Drug major LupinNSE -1.47 % is recalling 46,700 bottles of Morphine Sulfate extended-release tablets, used to treat severe pain, in the US market, according to a report by the US health regulator. Lupin Somerset is recalling the drug in various strengths due to “failed impurities/degradation specifications”, the latest enforcement report by the US Food and Drug Administration (USFDA) said.
“Product was shipped to five wholesalers and one supermarket chain who may have further distributed the product throughout the US,” it added.
ZydusNSE 0.48 % Pharmaceuticals USA Inc, a subsidiary of Zydus Cadila, is also recalling 7,668 bottles of Carvedilol Tablets, used to treat high blood pressure, in the American market.
The drug firm is recalling the drug due to the “presence of foreign tablets/capsules”, the USFDA 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 3.125mg,” it added.
The USFDA classified both the recalls as Class III.
A Class III recall by the USFDA is initiated in a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.