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Class III: unlikely to cause harmTerminated

Mylan Pharmaceuticals Triamterene and Hydrochlorothiazide Tablets Recall

Triamterene and Hydrochlorothiazide Tablets, USP 37

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class III
Reported by FDA
Jul 18, 2018
Recall ID
D-0978-2018
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Triamterene and Hydrochlorothiazide Tablets starting Jul 9, 2018. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0978-2018 on Jul 18, 2018. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01

Lot numbers, UPCs & expiration codes

Lot #: 2007979, Exp. 11/30/2020

Where it was sold

Nationwide within the United States

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-0978-2018
Classification
Class III
Status
Terminated
Recall initiated
Jul 9, 2018
FDA report date
Jul 18, 2018
Quantity
28,436 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0978-2018, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
80454
Address
781 Chestnut Ridge Rd
Code information
Lot #: 2007979, Exp. 11/30/2020
Postal code
26505-2730
Report date
Jul 18, 2018
Product type
Drugs
Recall number
D-0978-2018
Classification
Class III
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
28,436 bottles
Termination date
Jan 16, 2020
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
Distribution pattern
Nationwide within the United States
Recall initiation date
Jul 9, 2018
Initial firm notification
Letter
Center classification date
Jul 24, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0978-2018, published Jul 18, 2018. 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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