Home / Recalls / Mylan Pharmaceuticals Inc. / D-0877-2018

D-0877-2018 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
June 20, 2018
Initiation Date
June 7, 2018
Termination Date
June 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

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