Lupin recalls over 6 lakh bottles of hypertension drug in U.S.: USFDA

The USFDA reports states that the affected lot is manufactured at Lupin’s Goa-based manufacturing facility. File
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Drug firm Lupin is recalling over six lakh bottles of a medication indicated for high blood pressure in the U.S. due to deviation from current good manufacturing practices (CGMP), according to the U.S. health regulator.

As per its latest Enforcement Report, U.S. Food and Drug Administration (USFDA), stated that Dr. Reddy’s Laboratories is also recalling a product in the U.S. due to a manufacturing issue.

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, the U.S. health regulator said.

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 U.S. 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.

In a separate listing, USFDA stated that a U.S.-based unit of Dr. Reddy’s Laboratories is recalling 3,416 Made in India bottles of IBU (ibuprofen) 600 mg tablets in the U.S.

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

The company initiated the voluntary recall on October 29.

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.”