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.

FDA recall notice · announced June 30, 2021 · Bausch Health

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 19D012P, Exp Date 07/2021; 20D096P, Exp Date 10/2022
Quantity: 2,691 bottles
Status: Terminated
Products in this recall event:
- Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30 (D-0639-2021)
- 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. (D-0638-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.