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.
Who it affects
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-0219-2026Don't want to check this manually?
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