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Lupin Pharmaceuticals Inc.: Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, N

DrugsSource: FDA (drug) · Date: 2025-12-17

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Lupin Pharmaceuticals Inc.
Product
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Reason / hazard
Defective container - seal not adhering to bottles
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide.
Recall initiated
2025-11-05
Code info
Lot # QB00865, exp. date Feb 2028
Product quantity
52,128 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Naples
State
FL
Country
United States
Event id
97936
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