Recalls / Class II
Class IID-1055-2023
Product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
- Affected lot / code info
- Lot: 17-270530, Exp. 7/16/2023; 17-270871, Exp. 7/20/2023; 17-271153, Exp. 7/25/2023; 17-271275, Exp. 7/26/2023; 17-271417, Exp. 7/30/2023; 17-271671, Exp. 8/2/2023; 17-271883, Exp. 8/7/2023; 17-271992, Exp. 8/8/2023; 17-272050, Exp. 8/9/2023; 17-272103, Exp. 8/10/2023; 17-272368, 17-272369, Exp. 8/15/2023; 17-272451, Exp. 8/16/2023; 17-273172, Exp. 8/29/2023; 17-273782, 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
- 2,389 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-1055-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.