FDA Drug recall D-0244-2021
Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals Nort…
- FDA Drug
- Class III
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class III recall of Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals Nort… by Bausch Health Companies, citing failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0244-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-01-07 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bausch Health Companies |
| Distribution | US |
Product
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
Reason
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Identifiers
| code_info | Lot: 18L091P, Exp 05/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0244-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.