Drug recall
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals…
FDA recall event 88079 · Class III · Bausch Health Companies, Inc.
Key facts
| Event ID | 88079 |
|---|---|
| Recall numbers | D-0638-2021, D-0639-2021 |
| Recalling firm | Bausch Health Companies, Inc. |
| Product type | Drugs |
| Products | 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., 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 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Jun 8, 2021 |
| Report date | Jun 30, 2021 |
| Termination date | Feb 16, 2023 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3010446985 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: