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Glenmark Recalls US Products Over Manufacturing Issues

14 Oct 2024 , 01:22 PM

Glenmark Pharmaceuticals is recalling two medicines in the United States owing to manufacturing concerns, according to the Food and Drug Administration.

Glenmark Pharmaceuticals Inc, USA, issued a countrywide (US) Class II recall on September 24 this year.

According to the FDA, a Class II recall is undertaken when the use or exposure to a violative product may result in transitory or medically recoverable adverse health effects, or when the likelihood of substantial adverse health consequences is low.

Glenmark Pharmaceuticals Inc, USA, a subsidiary of Glenmark Pharmaceuticals, Mumbai, is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray.

According to the US Food and Drug Administration’s (USFDA) latest enforcement report, the corporation is recalling the concerned lot owing to a “defective delivery system”.

“The dip tube is clogged causing the spray not to work,” according to it.

According to the US Food and Drug Administration, the pharmaceutical company is also recalling a generic medication used to treat certain fungal skin diseases.

Glenmark Pharmaceuticals Inc., of the United States, is recalling 11,568 tubes of Ciclopirox Gel produced at the company’s Goa-based plant owing to a “defective container,” according to the FDA.

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Related Tags

  • Glenmark Pharmaceuticals
  • USA
  • USFDA
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