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

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-26T11:30:27+05:30 | Updated On 26 Nov 2024 11:30 AM IST

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."

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.

Read also: Dr Reddy's Labs, FDC recall generic medications in US over manufacturing issues

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751