Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30

FDA recall notice · announced February 3, 2021 · Bausch Health

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

The product

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot: 18L091P, Exp 05/2021
Quantity: 14,089 bottles
Status: Terminated
Products in this recall event:
- Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05 (D-0243-2021)
- Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30 (D-0244-2021)

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