Dr Reddy's Labs unit, Lupin arm recall products in US

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-11-26 06:00 GMT   |   Update On 2024-11-26 06:00 GMT
Advertisement

Dr Reddy's Labs, Lupin are recalling products in the US, according to the US Food and Drug Administration (USFDA).

A US-based unit of Dr Reddy's Laboratories is recalling 3,416 Made in India bottles of IBU (ibuprofen) 600 mg tablets in the US.

Princeton (NJ) based Dr Reddy's Laboratories, Inc initiated the Class III recall due to "Failed Tablet/Capsule Specifications," USFDA said.

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."

Advertisement

The company initiated the voluntary recall on October 29.

Baltimore-based Lupin Pharmaceuticals Inc, a subsidiary of Mumbai-based Lupin, is recalling 6,16,506 bottles of Ramipril capsules in strengths of 2.5 mg, 5 mg and 10 mg indicated for high blood pressure in the US due to deviation from current good manufacturing practices (CGMP), according to PTI.

The affected lot is manufactured at Lupin's Goa-based manufacturing facility, it stated.
The company is recalling 1,12,770 bottles of 2.5 mg tablets; 1,46,322 bottles of 5 mg tablets and 3,57,414 bottles of 10 mg tablets, it said.
The US health regulator noted that the company is undertaking Class II voluntary recall due to "CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor."
Lupin Pharmaceuticals Inc initiated the recall on October 23 this year.
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.
Tags:    
Article Source : with inputs

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.

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 .

Similar News