Lupin recalls birth control pill Mibelas 24 Fe in US over failed impurities specification
The reason for the recall is" failed impurities/degradation specifications: Out of specification result observed in related substance test", the USFDA said.
Advertisement
New Delhi: Drug major Lupin is recalling 5,60,922 pouches of a birth control product in the US, as per the US Food and Drug Administration (USFDA).
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
The product is used to prevent pregnancy. It is manufactured in India and then supplied in the US market by Lupin Pharmaceuticals Inc, the report said.
One pouch of Mibelas 24 Fe contains 28 chewable tablets.
The reason for the recall is "failed impurities/degradation specifications: Out of specification result observed in related substance test", the USFDA said.
The nationwide (US) recall was initiated by the company on July 21 this year and the USFDA classified it as a Class II recall.
As per the US health regulator, 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.
The company did not elaborate if the product is also sold in India. A mail sent to the company in this regard remained unanswered.
Usually, drug firms cater to the domestic market from separate manufacturing plants. The USFDA approved facilities are specifically utilised to cater to the US, the largest market for pharmaceutical products in the world.
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.