Why it was recalled
Failed Impurity/Degradation Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023)
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0160-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 9, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- 5,640 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0160-2023, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 91142
- Address
- 1101 C Ave W
- Code information
- Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023)
- Postal code
- 47274-3342
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0160-2023
- Classification
- Class III
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 5,640 bottles
- Termination date
- Jun 8, 2023
- Reason for recall
- Failed Impurity/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Nov 9, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2023