D-0639-2021 Class III Terminated
FDA drug recall D-0639-2021 was initiated by Bausch Health Companies, Inc. on Jun 8, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Feb 16, 2023). Affected quantity: 37,797 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 30, 2021
- Initiation Date
- Jun 8, 2021
- Termination Date
- Feb 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,797 bottles
Product description
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
Reason for recall
Failed Impurities/Degradation Specifications
Distribution pattern
Nationwide within the United States
Code information
Lot #:19D013P, Exp Date 07/2021; 20D099P, Exp Date 10/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0639-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026