Status
Terminated
Drug Enforcement D-1077-2023
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
- PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
- Product quantity
- 10,494 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-1077-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270678, 17-270695, Exp. 7/18/2023; 17-270880, Exp. 7/20/2023; 17-271075, Exp. 7/24/2023; 17-271233, 17-271269, Exp. 7/26/2023; 17-271492, 17-271494, Exp. 7/31/2023; 17-271748, Exp. 8/3/2023; 17-271891, Exp. 8/7/2023; 17-271945, Exp. 8/8/2023; 17-272221, 17-272236, Exp. 8/13/2023; 17-272286, 17-272305, Exp. 8/14/2023; 17-272642, Exp. 8/20/2023; 17-272997, 17-272998, Exp. 8/24/2023; 17-273478, 17-273496, 17-273497, Exp. 9/4/2023; 17-274139, 17-274156, 17-274163, Exp. 9/13/2023.
- More code info
- —