Recalls / Class II
Class IID-1058-2023
Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
- Affected lot / code info
- Lot: 17-270770, Exp. 7/19/2023; 17-271061, Exp. 7/24/2023; 17-271419, Exp. 7/30/2023; 17-271678, Exp. 8/2/2023; 17-272124, Exp. 8/10/2023; 17-272302, Exp. 8/14/2023; 17-272518, Exp. 8/17/2023; 17-273493, Exp. 9/4/2023; 17-273671, Exp. 9/6/2023.
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
- 2,077 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-1058-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.