Lupin and Aurobindo Pharma initiates nationwide recall of certain medications in the US market:
The latest enforcement report of the USFDA[1] has led to the recall of certain medications by two major pharma companies. The companies involved are Lupin and Aurobindo Pharma. These drug firms are recalling some of their products from the American market.
Lupin Pharmaceuticals recalls Oseltamivir Phosphate.
Baltimore – based unit of Lupin Pharmaceuticals Inc. has been actively recalling an antiviral medication. This medication is called Oseltamivir Phosphate for Oral suspension, and over 46,479 bottles are being recalled.
This product was manufactured at the manufacturing plant of the company in Aurangabad, Maharashtra. The nationwide recall was initiated on 21 January 2021 due to “failed impurities/degradation specifications.” This type of recall is categorized as a class III recall by the USFDA. Such a situation occurs when the use or exposure to the violative products does not cause any adverse effect.
Aurobindo Pharma- recalls Acetaminophen injection.
The Hyderabad – based drug maker, Aurobindo Pharma, is also undertaking similar measures to recall Acetaminophen injection.
Acetaminophen injection is used to treat moderate pain and fever. Over 3,094 cartons are being recalled, and this is initiated by the East Windsor-based unit of the company. The lots that are being recalled have been manufactured in India, and this action began on 30 December 2020. AuroMedics Pharma has announced that this recall is due to the “failed discoloration and pH specifications” of the product.
As per USFDA, this recall is classified as a Class II recall. This type of recall is put into effect when the use or exposure to the violative product causes temporary or medically reversible side effects.
This recall is also initiated when the products involved have slim chances of causing severe adverse effects.
Abbreviation: 1. The United States Food and Drug Administration
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