Status
Terminated
Drug Enforcement D-1058-2023
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, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
- Product quantity
- 2,077 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-1058-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270770, Exp. 7/19/2023; 17-271061, Exp. 7/24/2023; 17-271419, Exp. 7/30/2023; 17-271678, Exp. 8/2/2023; 17-272124, Exp. 8/10/2023; 17-272302, Exp. 8/14/2023; 17-272518, Exp. 8/17/2023; 17-273493, Exp. 9/4/2023; 17-273671, Exp. 9/6/2023.
- More code info
- —