D-0877-2018 Class III Terminated
FDA drug recall D-0877-2018 was initiated by Mylan Pharmaceuticals Inc. on Jun 7, 2018 and is designated Class III. Reason for recall: Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification. The recall status is terminated (terminated Jun 20, 2019). Affected quantity: 1,620 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 20, 2018
- Initiation Date
- Jun 7, 2018
- Termination Date
- Jun 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,620 bottles
Product Description
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Reason for Recall
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Distribution Pattern
Product was distributed throughout the United States
Code Information
Lot #: 3087136, Exp 5/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0877-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026