FDA-Drug2025-12-17Class IIIMISBRANDING
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide
Affected count
4800 54-count bottles
Manufactured in
600 College Rd E Ste 4000, N/A, Princeton, NJ, United States
Products
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0219-2026Want us to check the next one for you?
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