Status
Completed
Drug Enforcement D-0296-2023
Lack of sterility assurance
Classification
Class II
Report Date
February 22, 2023
Termination Date
—
Product Information
- Product description
- HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50
- Product quantity
- 37 bags
- Reason for recall
- Lack of sterility assurance
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Dispensed to Patients Nationwide.
Location & Firm
- Recalling firm
- Sentara Infusion Services
- Address
-
535 Independence Pkwy Ste 300, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0296-2023
- Event ID
- 91466
- Recall initiation date
- December 27, 2022
- Center classification date
- February 15, 2023
- Code info
- Beyond Use Date: December 24-31, 2022
- More code info
- —