Recalls / Class II
Class IID-1049-2023
Product
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
- Affected lot / code info
- Lot: 17-270675, 17-270683, Exp. 7/18/2023; 17-271147, 17-271119, Exp. 7/25/2023; 17-271339, Exp. 7/27/2023; 17-271679, Exp. 8/2/2023; 17-272202, Exp. 8/10/2023; 17-272241, Exp. 8/13/2023; 17-272375, Exp. 8/15/2023; 17-272783, Exp. 8/22/2023; 17-273438, 17-273431, Exp. 9/3/2023; 17-273615, Exp. 9/5/2023; 17-273789, 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
- 2,228 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-1049-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.