Mylan Pharmaceuticals Inc. recalls Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmac…
- Recall date
- June 7, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0877-2018
- FDA classification
- Class III
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Product was distributed throughout the United States
Why it was recalled
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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