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

FDA recall notice · announced January 25, 2023 · Lannett

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed Impurity/Degradation Specifications

Notes

Distribution: Nationwide USA
Lot/code information: Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
Quantity: 20,040 bottles
Status: Terminated
Products in this recall event:
- Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10 (D-0160-2023)
- 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: 052 (D-0161-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.