Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
Lot numbers, UPCs & expiration codes
Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
Where it was sold
Nationwide within 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-0638-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 8, 2021
- FDA report date
- Jun 30, 2021
- Quantity
- 2,691 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch Health Companies, Inc.
Original FDA data
Every field from FDA enforcement report D-0638-2021, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88079
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
- Postal code
- 08807-2867
- Report date
- Jun 30, 2021
- Product type
- Drugs
- Recall number
- D-0638-2021
- Classification
- Class III
- Recalling firm
- Bausch Health Companies, Inc.
- Product quantity
- 2,691 bottles
- Termination date
- Feb 16, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 8, 2021
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2021