FDA Drug Class III — Least Serious

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Hazard

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

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Products

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot # F2400244, Exp Date: 10/31/2026

Units Affected

4800 54-count bottles

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