Dr. Reddy’s Laboratories and Lupin are voluntarily recalling certain products in the United States, as reported by the U.S. Food and Drug Administration (USFDA).
A U.S.-based subsidiary of Dr. Reddy’s Laboratories is recalling 3,416 bottles of Made-in-India Ibuprofen (IBU) 600 mg tablets due to “Failed Tablet/Capsule Specifications.” The Princeton, New Jersey-based unit initiated the Class III recall on October 29. According to the USFDA, a Class III recall involves situations where the use of a non-compliant product is unlikely to cause adverse health consequences.
Meanwhile, Lupin Pharmaceuticals Inc., the Baltimore-based subsidiary of Mumbai-headquartered Lupin, is recalling 616,506 bottles of Ramipril capsules used for treating high blood pressure. The recall affects capsules in strengths of 2.5 mg, 5 mg, and 10 mg, manufactured at Lupin’s Goa facility.
The Class II recall, initiated on October 23, was due to “CGMP Deviations” related to sourcing the active pharmaceutical ingredient from an unapproved vendor. Class II recalls indicate that use or exposure to the product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious consequences.
The breakdown of the affected Ramipril lots includes:
- 2.5 mg capsules: 112,770 bottles
- 5 mg capsules: 146,322 bottles
- 10 mg capsules: 357,414 bottles
Both companies are taking proactive measures to address the quality concerns and ensure compliance with USFDA regulations.