Why it was recalled
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
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
Lot numbers, UPCs & expiration codes
Lot #: 3087136, Exp 5/20
Where it was sold
Product was distributed throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0877-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 7, 2018
- FDA report date
- Jun 20, 2018
- Quantity
- 1,620 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0877-2018, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 80261
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 3087136, Exp 5/20
- Postal code
- 26505-2730
- Report date
- Jun 20, 2018
- Product type
- Drugs
- Recall number
- D-0877-2018
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 1,620 bottles
- Termination date
- Jun 20, 2019
- Reason for recall
- Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Jun 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2018