USFDA Recall: Glenmark, Granules, Zydus, and Other Indian Drugmakers Issue Voluntary Recalls
Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus, and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA). The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report.
Glenmark’s Azelaic Acid Gel Recall
A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company’s Goa plant due to ‘CGMP deviations’ following market complaints received for gritty texture, the USFDA said. New Jersey-based Glenmark Pharmaceuticals Inc., USA, initiated the Class II nationwide recall on September 17.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. Learn more about the pharmaceutical industry.
Granules India’s Dextroamphetamine Saccharate Recall
Hyderabad-based Granules India is recalling over 49,000 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, extended-release capsules in multiple strengths due to ‘failed impurities/degradation specifications’, USFDA said. The US-based arm of the company issued the Class III recall on August 28.
As per the USFDA, a Class III recall is initiated in a ‘situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences’. This is not the first time Indian drugmakers have faced issues with the USFDA. Read more about USFDA guidelines.
Sun Pharma’s Renal Imaging Agent Recall
The US health regulator stated that a US-based subsidiary of the drug major Sun Pharma is recalling 1,870 kits of renal imaging agent. The Class II recall announced on September 3 is due to the failed dissolution specifications, it added.
Zydus Pharmaceuticals’ Entecavir Tablets Recall
Zydus Pharmaceuticals (USA) Inc, a unit of Ahmedabad-based drugmaker, is recalling 8,784 bottles of antiviral drug Entecavir tablets, due to ‘failed impurity/ degradation specifications,’ the USFDA stated. The company initiated the Class II recall on September 4.
Unichem Pharmaceuticals’ Label Mix-Up Recall
Another drug firm Unichem Pharmaceuticals USA Inc is recalling 230 90-count bottles for label mix-up, the USFDA said. The East Brunswick-based firm issued the Class I recall on August 27, it added.
Impact on Indian Investors
India has the highest number of USFDA-compliant pharmaceutical plants outside of the US. The recalls may impact the stock prices of these companies in the short term. However, it is essential for investors to understand that these recalls are voluntary and may not necessarily affect the long-term prospects of these companies. Learn more about investing in pharmaceuticals.
Conclusion
In conclusion, the USFDA recalls issued by Glenmark, Granules India, Zydus, and other Indian drugmakers are a reminder of the importance of quality control and compliance with regulatory guidelines. While these recalls may have a short-term impact on the stock prices of these companies, they do not necessarily affect their long-term prospects. Indian investors should continue to monitor the situation and stay informed about the latest developments in the pharmaceutical industry.