Recalls / Class II
Class IID-0324-2023
Product
VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Affected lot / code info
- Beyond Use DateL December 29, 2022
Why it was recalled
Lack of sterility assurance
Recalling firm
- Firm
- Sentara Infusion Services
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 535 Independence Pkwy Ste 300, N/A, Chesapeake, Virginia 23320-5176
Distribution
- Quantity
- 1 bag
- Distribution pattern
- Dispensed to Patients Nationwide.
Timeline
- Recall initiated
- 2022-12-27
- FDA classified
- 2023-02-15
- Posted by FDA
- 2023-02-22
- Terminated
- 2026-02-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0324-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.