Recalls / Class III
Class IIID-0877-2018
Product
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
- Affected lot / code info
- Lot #: 3087136, Exp 5/20
Why it was recalled
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 1,620 bottles
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2018-06-07
- FDA classified
- 2018-06-15
- Posted by FDA
- 2018-06-20
- Terminated
- 2019-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0877-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.