Drugmakers Aurobindo Pharma, Glenmark and FDC are recalling products in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA).
Aurobindo Pharma USA Inc, a unit of the Hyderabad-based pharmaceutical major, is recalling 240 bottles of its pain relief drug Healthy Living, which consists of acetaminophen, aspirin (NSAID) and caffeine tablets.
According to the USFDA’s latest compliance report, the company is recalling the affected lot due to “missing labeling.”
Some bottles are missing the manufacturer’s label that includes information about the drug’s facts, the U.S. health regulator said.
New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said.
According to the US health regulator, a Class I recall refers to defective products that can cause serious health problems.
Similarly, a subsidiary of US-based Glenmark Pharmaceuticals is recalling 2,404 bottles of indomethacin extended-release capsules, produced in a Madhya Pradesh plant, due to “failed dissolution specifications,” the USFDA said.
Glenmark Pharmaceuticals Inc, USA initiated the Class II recall on July 31, it added.
The US FDA report said: MaharashtraNew York-based drugmaker FDC Ltd is recalling 1,76,784 bottles of timolol maleate ophthalmic solution USP due to “defective packaging.”
Patients are unable to draw the solution out of the bottle because the tip of the cap is lodged in the nozzle of the product bottle, he said.
The company initiated the Class II recall on August 12 of this year.
According to the US FDA, a Class II recall is initiated in a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote.
India has the largest number of FDA-compliant pharmaceutical plants outside the United States.
Disclaimer:
The information contained in this post is for general information purposes only. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the post for any purpose.
We respect the intellectual property rights of content creators. If you are the owner of any material featured on our website and have concerns about its use, please contact us. We are committed to addressing any copyright issues promptly and will remove any material within 2 days of receiving a request from the rightful owner.