Recalls / Class II
Class IID-1057-2023
Product
HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
- Affected lot / code info
- Lot: 17-270683, Exp 7/18/2023; 17-271119, Exp 7/25/2023; 17-271339, Exp 7/27/2023; 17-272202, Exp 8/10/2023; 17-272241, Exp 8/13/2023; 17-272783, Exp 8/22/2023; 17-273431, Exp 9/3/2023; 17-273615, Exp 9/5/2023
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
- 1,389 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-1057-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.