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Class III: unlikely to cause harmTerminated

Lannett Triamterene and Hydrochlorothiazide Capsules Recall

Triamterene and Hydrochlorothiazide Capsules, USP (37

Lannett Company Inc. · Seymour, IN

Risk level
Class III
Reported by FDA
Jan 25, 2023
Recall ID
D-0160-2023
Check your lot numberHow we source this data

Summary

Lannett recalled Triamterene and Hydrochlorothiazide Capsules starting Nov 9, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0160-2023 on Jan 25, 2023. Reason: Failed Impurity/Degradation Specifications. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0160-2023, published Jan 25, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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