Aurobindo Pharma's US subsidiary has initiated a voluntary recall of more than 4,600 bottles of acetaminophen tablets from the American market following manufacturing quality issues that resulted in visible tablet discoloration.
Recall Details and Scope
Princeton-based Aurobindo Pharma USA Inc is recalling 4,608 bottles of Acetaminophen Tablets (325 mg) due to Current Good Manufacturing Practices (cGMP) deviations, according to the US Food and Drug Administration's latest Enforcement Report. The Class II recall was initiated on May 22, 2024.
The affected lot is being recalled "due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)," the FDA reported. This discoloration represents a deviation from established manufacturing standards that ensure drug quality and safety.
FDA Classification and Risk Assessment
The FDA has classified this as a Class II recall, which is initiated when the use of or exposure to a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. This classification indicates that while the product poses some risk, it is not considered immediately life-threatening.
Affected Medication and Uses
The recalled acetaminophen tablets are commonly used to relieve various types of pain, including headaches, migraines, toothaches, back pain, and muscle pain. Acetaminophen is one of the most widely used over-the-counter pain relievers and fever reducers in the United States.
Company Response
The Hyderabad-based pharmaceutical company took swift action to protect consumers upon receiving the complaints about tablet discoloration. The recall demonstrates the company's commitment to maintaining product quality standards and consumer safety.
Following the recall announcement, shares of Aurobindo Pharma were trading 0.08 percent higher at Rs 1,124.05 per share on the Bombay Stock Exchange, suggesting minimal immediate impact on investor confidence.
