Status
Terminated
Drug Enforcement D-1044-2023
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, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
- Product quantity
- 2,717 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-1044-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270603, Exp. 7/17/2023; 17-270802, Exp. 7/19/2023; 17-271073, Exp. 7/24/2023; 17-271129, Exp. 7/25/2023; 17-271254, Exp. 7/26/2023; 17-271953, Exp. 8/8/2023; 17-272022, Exp. 8/9/2023; 17-272295, Exp. 8/14/2023; 17-272616, Exp. 8/20/2023; 17-273357, Exp. 8/31/2023; 17-273501, Exp. 9/4/2023.
- More code info
- —