Information
Dr. Reddy's Laboratories Recalls Varenicline Tablets
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0219-2026Drug / Pharmaceutical
Dr. Reddy's Laboratories Recalls Varenicline Tablets
Dr. Reddy's Laboratories, Inc. · Class III — Regulatory
Product Description
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Reason for Recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Distributed Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database