FDA-Drug2023-01-25Class III

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10

Lannett Company Inc.
Hazard

Failed Impurity/Degradation Specifications

Sold states
Nationwide USA
Affected count
20,040 bottles
Manufactured in
1101 C Ave W, N/A, Seymour, IN, United States
Products
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2023

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