Recalls / Class III
Class IIID-0978-2018
Product
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
- Affected lot / code info
- Lot #: 2007979, Exp. 11/30/2020
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 28,436 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-07-09
- FDA classified
- 2018-07-24
- Posted by FDA
- 2018-07-18
- Terminated
- 2020-01-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0978-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.