Recalls / Class II
Class IID-1073-2023
Product
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
- Affected lot / code info
- Lot: 17-270545, Exp. 7/16/2023; 17-270614, Exp. 7/17/2023; 17-270885, 17-270897, Exp. 7/20/2023; 17-270980, 17-270992, Exp. 7/23/2023; 17-271268, Exp. 7/26/2023; 17-271338, Exp. 7/27/2023; 17-271426, 17-271428, Exp. 7/30/2023; 17-271691, Exp. 8/2/2023; 17-271843, Exp. 8/6/2023; 17-271963, Exp. 8/8/2023; 17-272136, Exp. 8/10/2023; 17-272215, Exp. 8/13/2023; 17-272304, Exp. 8/14/2023; 17-272379, Exp. 8/15/2023; 17-272462, Exp. 8/16/2023; 17-272641, Exp. 8/20/2023; 17-272698, Exp. 8/21/2023; 17-273602, 17-273627, Exp. 9/5/2023; 17-273883, Exp. 9/10/2023.
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
- 8,942 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-1073-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.