Jul 25, 2022 After manufacturing errors, Sun Pharma and Glenmark recall generic products in the US

Glenmark Baddi plant 
Glenmark’s Baddi plant in Himachal Pradesh, India, was responsible for faulty packaging, leading to the recall of 23 lots of a corticosteroid lotion. (Glenmark)
Two Indian manufacturers of generic drugs—Sun Pharma and Glenmark—landed on the FDA’s weekly enforcement report for recalls in the United States.

On June 21, Sun Pharma initiated a voluntary recall of 50,680 vials of testosterone cypionate injection because of “water leakage” and at a plant in Gujarat, India.

It is a Class II recall, which the FDA defines as one where use or exposure to a defective product could cause temporary or medically reversible adverse health consequences or where the probability of severe consequences is remote.

Meanwhile, Glenmark’s recall is for 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion which treats skin conditions such as eczema, psoriasis, allergies and rash.

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The recall, which was initiated on June 16, is for defective packaging and is considered a Class III recall, which means exposure to the product is unlikely to cause adverse health consequences.

Glenmark made the products in question at its plant in Himachal Pradesh, India. The recalled packs were all due for expiration between June of this year and October of next year. 

(FROM fiercepharma)