Recalls / Class III
Class IIID-0161-2023
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
- Affected lot / code info
- Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
Why it was recalled
Failed Impurity/Degradation Specifications
Recalling firm
- Firm
- Lannett Company Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1101 C Ave W, N/A, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 20,040 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-11-09
- FDA classified
- 2023-01-16
- Posted by FDA
- 2023-01-25
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0161-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.