Drug & medication recalls

Bausch Health Companies, Inc. recalls Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America…

Recall date
January 7, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0243-2021
FDA classification
Class III
Brand / firm
Bausch Health Companies, Inc.
Sold / distributed
Distributed Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

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