Dr Reddy's Laboratories is recalling 10,440
(90-count) and 2,24,710 (500 count) bottles of Atorvastatin Calcium tablets in the US
15 March, 2021 Mumbai; Leading home grown drug makers Sun Pharma, Dr Reddy's
Laboratories, Aurobindo Pharma and Jubilant Pharma are recalling products in the
US market, the world's largest market for pharmaceutical products, for various
Sun Pharma is recalling Cequa ophthalmic solution, which is used to treat chronic dry
eye, as per the latest Enforcement Report by the US Food and Drug Administration (USFDA).
The US-based subsidiary of the Mumbai-based drug major is recalling 37,400 cartons
(60 vials per carton) of the ophthalmic solution for being ''subpotent'', the US health
The Princeton (NJ) based 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 drug major 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
The drug firm 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.
''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.
Besides, Salisbury-based Jubilant Cadista Pharmaceuticals is recalling 6,35,400 cartons
of Methylprednisolone tablets, prescribed for its 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.