Recalls / Class II
Class IID-0031-2024
Product
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
- Affected lot / code info
- Lot: 17-275339, Exp. 10/3/2023; 17-275478, 17-275488, Exp. 10/4/2023; 17-275620, Exp. 10/8/2023; 17-275777, 17-275793, Exp. 10/10/2023; 17-275863, 17-275958, Exp. 10/11/2023; 17-276027, Exp. 10/16/2023; 17-275730, Exp. 10/9/2023.
Why it was recalled
Lack of assurance of sterility:
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
- 2,664 30 mL syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-09-21
- FDA classified
- 2023-10-04
- Posted by FDA
- 2023-10-11
- Terminated
- 2025-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0031-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.