Status
Terminated
Drug Enforcement D-1074-2023
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
- lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
- Product quantity
- 9,517 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-1074-2023
- Event ID
- 92752
- Recall initiation date
- July 17, 2023
- Center classification date
- August 3, 2023
- Code info
- Lot: 17-271076, Exp. 7/24/2023; 17-271132, 17-271165, Exp. 7/25/2023; 17-271230, 17-271250, Exp. 7/26/2023; 17-271508, Exp. 7/31/2023; 17-271595, 17-271604, Exp. 8/1/2023; 17-271658, Exp. 8/2/2023; 17-271764, Exp. 8/3/2023; 17-271826, Exp. 8/6/2023; 17-271972, Exp. 8/8/2023; 17-272052, 17-272057, Exp. 8/9/2023; 17-272139, Exp. 8/10/2023; 17-272258, Exp. 8/14/2023; 17-272470, Exp. 8/16/2023; 17-272690, Exp. 8/20/2023; 17-272822, Exp. 8/23/2023; 17-273054, 17-273065, Exp. 8/28/2023; 17-273423, Exp. 9/2/2023; 17-273771, Exp. 9/7/2023.
- More code info
- —