Cadila Healthcare arm recalls Metformin Hydrochloride ER tablets in US
Advertisement
New Delhi: Viona Pharmaceuticals Inc is recalling over 21,000 bottles of metformin hydrochloride extended-release tablets manufactured by Ahemdabad-based Cadila Healthcare, the latest enforcement report of the US Food and Drug Administration (USFDA) said.
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
Viona Pharmaceuticals Inc is recalling 21,240 bottles of metformin hydrochloride extended-release tablets, USP 750 mg, on account of "CGMP Deviations: FDA analysis detected n-nitrosodimethylamine (NDMA) levels in excess of the acceptable daily intake limit", the report by the US health regulator said.
The voluntary ongoing nationwide recall in the US is a class-II recall, it added.
As per USFDA, a class-II recall is initiated in a situation in which 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.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
Viona Pharmaceuticals Inc is a wholly-owned indirect subsidiary of Cadila Healthcare.
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.