Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Product description
Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
Lot numbers, UPCs & expiration codes
Lot: 18L092P, Exp 05/2021
Where it was sold
Distributed Nationwide in the USA
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-0243-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 7, 2021
- FDA report date
- Feb 3, 2021
- Quantity
- 895 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bausch Health Companies, Inc.
Original FDA data
Every field from FDA enforcement report D-0243-2021, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87093
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot: 18L092P, Exp 05/2021
- Postal code
- 08807-2867
- Report date
- Feb 3, 2021
- Product type
- Drugs
- Recall number
- D-0243-2021
- Classification
- Class III
- Recalling firm
- Bausch Health Companies, Inc.
- Product quantity
- 895 bottles
- Termination date
- Feb 11, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jan 7, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 25, 2021