Recalls / Class II
Class IID-1074-2023
Product
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
- Affected lot / 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.
Why it was recalled
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Recalling firm
- Firm
- Central Admixture Pharmacy Services Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7935 Dunbrook Rd Ste C, N/A, San Diego, California 92126-6322
Distribution
- Quantity
- 9,517 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-17
- FDA classified
- 2023-08-03
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1074-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.