Status
Terminated
Drug Enforcement D-1049-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 21, 2025
Product Information
- Product description
- HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
- Product quantity
- 2,228 syringes
- Reason for recall
- Lack of assurance of sterility: Lack of validation data for sanitization cycles
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services Inc
- Address
-
7935 Dunbrook Rd Ste C, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1049-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270675, 17-270683, Exp. 7/18/2023; 17-271147, 17-271119, Exp. 7/25/2023; 17-271339, Exp. 7/27/2023; 17-271679, Exp. 8/2/2023; 17-272202, Exp. 8/10/2023; 17-272241, Exp. 8/13/2023; 17-272375, Exp. 8/15/2023; 17-272783, Exp. 8/22/2023; 17-273438, 17-273431, Exp. 9/3/2023; 17-273615, Exp. 9/5/2023; 17-273789, 9/7/2023.
- More code info
- —