Industry

Drug recall: Dr Reddy’s, Sun Pharma recall these drugs due to this reason

As per 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 Health Master

December 5, 2022

1027

Last Updated on December 31, 2023 by The Health Master

New Delhi: Drug majors Dr. Reddy’s Laboratories and Sun Pharma are recalling different products in the US market for manufacturing issues, according to the US Food and Drug Administration (USFDA).

Dr. Reddy’s Laboratories

As per the enforcement report by the US health regulator, the US-based arm of Dr. Reddy’s Laboratories is recalling over 48,000 cartons of a drug used to treat sneezing, runny, or stuffy nose.

It is recalling 25,176 cartons of 30-count tablets and 22,968 cartons of 20-count tablets.

According to USFDA, Dr. Reddy’s Laboratories is recalling the affected lot due to “failed stability specifications”.

New Jersey-based Dr. Reddy’s Laboratories, Inc initiated the Class III recall on November 21 this year.

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.”

Click for more articles on USFDA

Sun Pharmaceuticals

The health regulator further said the US-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease (GERD).

The company is recalling the affected lot, produced at its Mohali plant, due to “discoloration”, it added.

Sun Pharmaceutical Industries Inc commenced the Class II voluntary recall in the US on July 25 this year.

As per 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.

According to industry estimates, the US generic drug market was estimated at around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Other drugs recall

Drug recall: FDA issues nationwide recall for Ferric Carboxymaltose

Drug recall: These drugs recalled by Aurobindo for this reason

Drug recall: These products recalled by Dr Reddy’s, Cipla, and Aurobindo

Drug recall: Sodium Bicarbonate Injection recalled due to this reason

Drug recall: Acyclovir Sodium Injection recalled due to this reason

Drug recall: Zydus, Lupin recall products due to this issue

Also read

USFDA gives nod for Diclofenac Sodium topical solution

IPC releases amendment list for IP 2022, details here

NPPA releases 2nd list with draft ceiling prices for 43 formulations

USFDA gives approval for Venlafaxine ER tablets