FDA DrugClass II

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

Defective container - seal not adhering to bottles…

From the FDA notice · Read the official notice ↗ · All Lupin recalls

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Product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
52,128 bottles
Illnesses reported
None reported
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Classification
Class II
Recall number
D-0227-2026

In the FDA's words

Description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. Defective container - seal not adhering to bottles Lot # QB00865, exp. date Feb 2028 Distribution: Nationwide. Affected quantity: 52,128 bottles
Hazard
Defective container - seal not adhering to bottles

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