Glenmark Pharma recalls 6528 bottles of BP drug in US
Advertisement
New Delhi: Glenmark Pharmaceuticals is recalling 6,528 bottles of a medication prescribed for the treatment of high blood pressure in the American market. The decision comes in response to failed dissolution specifications, as stated by the US health regulator.
The US-based arm of the Mumbai-headquartered drug firm is recalling the affected lot of Diltiazem Hydrochloride extended-release capsules, the US Food and Drug Administration said in its latest Enforcement Report.
The affected lot has been produced in India and is being recalled by New Jersey-based Glenmark Pharmaceuticals Inc for "failed dissolution specifications", the USFDA said.
"Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study," it noted.
Glenmark initiated Class II recall of the drug across the US on March 26 this year, as per PTI reported.
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe and the US as the main destinations.
India has the highest number of USFDA-compliant companies with plants outside of the US. As per the fiscal year, 2022 report on State of Pharmaceutical Quality published by USFDA, India boasts of more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the US.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.