Sun Pharma, Dr Reddy’s, Aurobindo, Jubilant recall products in US
The Indian firms have initiated recall of these products for various reasons including failed impurities/degradation specifications, failed dissolution specifications, presence of foreign tablets, illegible label etc
Sun Pharma, Dr Reddy’s Laboratories, Aurobindo Pharma and Jubilant Pharma are recalling products in the US market for various reasons.
As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling Cequa ophthalmic solution, which is used to treat chronic dry eye.
The US-based subsidiary of the Mumbai-based company is recalling 37,400 cartons (60 vials per carton) of the ophthalmic solution for being “subpotent”, the US health regulator said.
The firm initiated the nationwide recall of the affected lot on February 22, this year, it added.
Similarly, Dr Reddy’s Laboratories is recalling 10,440 (90-count) and 2,24,710 (500 count) bottles of Atorvastatin Calcium tablets in the US market.
The Hyderabad-based firm is recalling the drug, which is used to prevent cardiovascular disease, for “failed impurities/degradation specifications”, the USFDA said.
The US-based unit of the company initiated the nationwide recall on February 19, 2021, and the USFDA has categorised it as Class III recall which is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.
It is also recalling 16,449 bottles of Progesterone Capsules (200 mg), used to cause menstrual periods in women who have not yet reached menopause, in the US market for “failed dissolution specifications”.
The company has initiated the nationwide recall of the lot on February 26, this year and the USFDA has classified it as a Class II recall which is initiated in a situation in which 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.
Aurobindo Pharma is recalling 1,296 bottles of Famotidine tablets, used to treat gastroesophageal reflux disease, in the US market for the presence of foreign tablets.
“Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg,” the USFDA noted.
The company initiated the nationwide recall on January 20 and the USFDA has classified the action as Class II.
Jubilant Cadista Pharmaceuticals is recalling 6,35,400 cartons of Methylprednisolone tablets, prescribed for their anti-inflammatory and immunosuppressive effects, in the American market due to “illegible label”.
“Customer complaint received of misalignment print of the printed dosing instructions on the blister card,” the USFDA said.
The company initiated the nationwide recall on February 19 and the USFDA has classified the action as a Class III recall.
Jubilant Cadista Pharmaceuticals is a subsidiary of Singapore-based Jubilant Pharma, which in turn is a wholly-owned subsidiary of Noida-based Jubilant Life Sciences.
(Edits by EP News Bureau)