INDIA – Generic drug makers Granules India and Jubilant Cadista are recalling different products in the US, the world’s largest market for medicines, for different reasons.
As per the latest Enforcement Report by US Food and Drug Administration (USFDA), the US-based unit of Granules India is recalling a batch of Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever.
According to USFDA, the company’s US-based unit is recalling the affected lot due to “Current Good Manufacturing Practice (CGMP) deviations”.
The affected lot has been manufactured at Granules India’s Telangana-based plant. The lot has been distributed in the US by New Jersey-based Granules USA, Inc, the report stated.
“Granules manufactured and released a batch using Active Pharmaceutical Ingredient (API) from an alternate source prior to the final approval of a filed Prior Approval Supplement. We have since received the authorisation to use the API for this ANDA. There was absolutely no harm done at a patient level because the API used in the batch is from an FDA approved source,” GN Prashanth, Senior Vice President & Head Corporate Quality Assurance – Granules India Ltd said in a release.
Granules has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date, it added.
As per USFDA, a Class II recall 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.
USFDA further said US-based Jubilant Cadista Pharmaceuticals Inc is recalling 14,544 bottles of Donepezil HCL Tablets, which is used to treat mild to moderate dementia in Alzheimer’s disease.
The company is recalling the affected lot due to it being “subpotent,” it added.
Jubilant Cadista Pharmaceuticals is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.
The affected lot has been produced by Jubilant Generics in India and marketed in the US by Salisbury-based Jubilant Cadista Pharmaceuticals, Inc. Jubilant commenced the Class III recall in the US on August 20, 2021.
As per USFDA, 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.”
According to industry estimates, the US generic drug market was estimated to be around US$115.2 billion in 2019. It is the largest market for pharmaceutical products.