FDA-Drug2018-06-20Class III

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

Mylan Pharmaceuticals Inc.
Hazard

Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

Sold states
Product was distributed throughout the United States
Affected count
1,620 bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0877-2018

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