D-0978-2018 Class III Terminated
FDA drug recall D-0978-2018 was initiated by Mylan Pharmaceuticals Inc. on Jul 9, 2018 and is designated Class III. Reason for recall: Subpotent Drug The recall status is terminated (terminated Jan 16, 2020). Affected quantity: 28,436 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 18, 2018
- Initiation Date
- Jul 9, 2018
- Termination Date
- Jan 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,436 bottles
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
Reason for Recall
Subpotent Drug
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 2007979, Exp. 11/30/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0978-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026