AVKARE Inc.: Drug Recall
Recall #D-0631-2021 · 06/09/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0631-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- AVKARE Inc.
- Status
- Terminated
- Date Initiated
- 06/09/2021
- Location
- Pulaski, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 cartons
Reason for Recall
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Product Description
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Distribution Pattern
Distributed in Los Angeles California
Other Recalls by AVKARE Inc.
- Class III: Low Risk 07/20/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.