Sun Pharma and Glenmark are recalling products in the US due to lapses in the manufacturing process.
As per the latest enforcement report by the US Food and Drug Administration (USFDA), a US-based unit of Sun Pharma is recalling 50,680 vials of Testosterone Cypionate Injection, used to treat low testosterone in adult males, in the American market.
According to the US health regulator, the company is recalling the affected lot due to “water leakage” leading to deviation from current good manufacturing practices (cGMP).
The company is also recalling 27 vials of the same medication due to cGMP deviations, USFDA said.
“Manufacturing deviations were reported due to an abnormal appearance on parts of machinery,” it added. The affected lot was produced at Sun Pharma’s Halol (Gujarat) based manufacturing plant.
Sun Pharmaceutical Industries Inc, a unit of the company, initiated the Class II nationwide (US) recall of the affected lots last month.
As per the 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.
Glenmark, on the other hand, is recalling 98,307 packs of Mometasone Furoate Topical Solution, a medication used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
Glenmark Pharmaceuticals is recalling the lot, which rolled out from the company’s Baddi (Himachal Pradesh) plant, due to a “Defective Container”, the USFDA stated.
The company initiated the nationwide recall, which the US health regulator classified as Class III, on June 16.
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.”
(Edits by EP News Bureau)