Recalls / Class III
Class IIID-0631-2021
Product
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
- Affected lot / code info
- Lot: 38617 Exp. 10/2022
Why it was recalled
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 10 cartons
- Distribution pattern
- Distributed in Los Angeles California
Timeline
- Recall initiated
- 2021-06-09
- FDA classified
- 2021-06-16
- Posted by FDA
- 2021-06-23
- Terminated
- 2023-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0631-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.