Status
Terminated
Drug Enforcement D-1078-2023
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, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
- Product quantity
- 16,971 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-1078-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-270510, 17-270512, Exp. 7/16/2023; 17-270665, 17-270699, Exp. 7/18/2023; 17-270812, Exp. 7/19/2023; 17-271062, 17-271063, 17-271064, 17-271065, Exp. 7/24/2023; 17-271350, 17-271357, 17-271421, 17-271422, Exp. 7/30/2023; 17-271836, 17-271848, Exp. 8/6/2023; 17-271890, Exp. 8/7/2023; 17-271943, 17-271954, 17-271958, 17-271962, Exp. 8/8/2023; 17-272162, 17-272174, 17-272175, 17-272176, 17-272177, Exp. 8/13/2023; 17-272444, 17-272456, 17-272473, Exp. 8/16/2023; 17-272717, 17-272721, 17-272732, Exp. 8/21/2023; 17-273550, 17-273565, 17-273579, 17-273580, Exp. 9/5/2023.
- More code info
- —