Status
Terminated
Drug Enforcement D-1060-2023
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 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
- Product quantity
- 5,259 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-1060-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270534, Exp. 7/16/2023; 17-270705, Exp. 7/18/2023; 17-270782, 17-270797, 17-270798, Exp. 7/19/2023; 17-270968, Exp. 7/23/2023; 17-271105, 17-271154, Exp. 7/25/2023; 17-271251, Exp. 7/26/2023; 17-271330, Exp. 7/27/2023; 17-271418, Exp. 7/30/2023; 17-271746, 17-271758, Exp. 8/3/2023; 17-272108, Exp. 8/10/2023; 17-272257, Exp. 8/13/2023; 17-272344, 17-272355, Exp. 8/15/2023; 17-272442, Exp. 8/16/2023; 17-272801, Exp. 8/22/2023; 17-273511, Exp. 9/4/2023; 17-273576, 17-273611, Exp. 9/5/2023; 17-274048, 17-274050, Exp. 9/12/2023.
- More code info
- —