Last Updated on October 15, 2024 by The Health Master
New Delhi: Unichem Pharmaceuticals USA Inc is recalling 18,960 bottles of the hypertension treatment medication Clonidine Hydrochloride tablets in the American market for product mix-up, according to the US Food and Drug Administration (USFDA).
As per the latest Enforcement Report by the US health regulator, the company, a unit of Mumbai-based Unichem Laboratories, is recalling the bottles due to a “product mix-up.
As per the USFDA, 0.2 mg strength Clonidine Hydrochloride Tablets, USP was found in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets.
An affected lot of tables have been manufactured by Unichem Laboratories in its Goa-based plant and distributed in the US market by New Jersey-based Unichem Pharmaceuticals USA Inc.
As per the USFDA, the company initiated the Class III recall on September 19 across the US.
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.”
According to industry estimates, the US generic drug market was estimated to be worth around USD 115.2 billion in 2019. It is the largest market globally for pharmaceutical products.
Drug recall: Acyclovir Sodium Injection recalled due to this reason
Drug recall: Zydus, Lupin recall products due to this issue
Drug recall: Glenmark, Strides Pharma, Cipla recalled these drugs
Drug recall: Glenmark, Sun, Dr Reddy’s recalled these Drugs
Drug recall: Atorvastatin 40 mg tablets recalled due to this reason
Drug recall: Magnesium Citrate Oral Solution recalled due to this reason
NPPA fixes Retail Prices of 40 Formulations: September 2022
USFDA tentative approves Amantadine extended-release capsules
API manufacturing finally getting the attention it deserves
USFDA gives nod for this generic drug for urinary issues
IPC launches 1000th IP Reference Standard
NDPS: Inter-state Pharmaceutical drug racket busted
USFDA issues 2 observations on Form 483 to Zydus Lifesciences
DCGI panel recommends ban on these Fixed dose combination drugs
Drug recall: Acyclovir Sodium Injection recalled due to this reason
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: