Status
Terminated
Drug Enforcement D-1052-2023
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 added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
- Product quantity
- 3824 bags
- 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-1052-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270599, 17-270600, Exp. 7/17/2023; 17-270785, Exp. 7/19/2023; 17-270969, Exp. 7/23/2023; 17-271116, 17-271135, Exp. 7/25/2023; 17-271242, Exp. 7/26/2023; 17-271502, Exp. 7/31/2023; 17-271561, 17-271589, Exp. 8/1/2023; 17-271672, Exp. 8/2/2023; 17-271837, Exp. 8/6/2023; 17-272291, Exp. 8/14/2023; 17-272363, 17-272364, Exp. 8/15/2023; 17-272453, Exp. 8/16/2023; 17-272607, Exp. 8/20/2023; 17-272706, Exp. 8/21/2023; 17-273148, Exp. 8/29/2023; 17-273421, Exp. 9/3/2023; 17-273698, 17-273700, Exp. 9/6/2023; 17-273966, Exp. 9/11/2023.
- More code info
- —