Status
Terminated
Drug Enforcement D-0161-2023
Failed Impurity/Degradation Specifications
Classification
Class III
Report Date
January 25, 2023
Termination Date
June 8, 2023
Product Information
- Product description
- 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
- Product quantity
- 20,040 bottles
- Reason for recall
- Failed Impurity/Degradation Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide USA
Location & Firm
- Recalling firm
- Lannett Company Inc.
- Address
-
1101 C Ave W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0161-2023
- Event ID
- 91142
- Recall initiation date
- November 9, 2022
- Center classification date
- January 16, 2023
- Code info
- Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
- More code info
- —