USFDA: Glenmark, Granules, Zydus Recall Products in US

New Delhi, Sep 28 (PTI) Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA).

The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report.

A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to "CGMP deviations" following market complaints received for gritty texture, USFDA said.

New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17.

As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

Hyderabad-based Granules India is recalling over 49,000 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, extended-release capsules in multiple strengths due to "failed impurities/degradation specifications", USFDA said.

The US-based arm of the company issued the Class III recall on August 28.

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 US health regulator stated that a US-based subsidiary of the drug major Sun Pharma is recalling 1,870 kits of renal imaging agent.

The Class II recall announced on September 3 is due to the failed dissolution specifications, it added.

Zydus Pharmaceuticals (USA) Inc, a unit of Ahmedabad-based drugmaker, is recalling 8,784 bottles of antiviral drug Entecavir tablets, due to "failed impurity/ degradation specifications," USFDA stated.

The company initiated the Class II recall on September 4.

Another drug firm Unichem Pharmaceuticals USA Inc is recalling 230 90-count bottles for label mix-up, USFDA said.

The East Brunswick-based firm issued the Class I recall on August 27, it added.

India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.