FDA-Drug2025-12-17Class IIPACKAGING DEFECT

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

TAMPERINGNationwide distribution
Hazard

Defective container - seal not adhering to bottles

Sold states
Nationwide.
Affected count
52,128 bottles
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Products
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2026

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