Recalls / Class II
Class IID-1060-2023
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: 17-270534, Exp. 7/16/2023; 17-270705, Exp. 7/18/2023; 17-270782, 17-270797, 17-270798, Exp. 7/19/2023; 17-270968, Exp. 7/23/2023; 17-271105, 17-271154, Exp. 7/25/2023; 17-271251, Exp. 7/26/2023; 17-271330, Exp. 7/27/2023; 17-271418, Exp. 7/30/2023; 17-271746, 17-271758, Exp. 8/3/2023; 17-272108, Exp. 8/10/2023; 17-272257, Exp. 8/13/2023; 17-272344, 17-272355, Exp. 8/15/2023; 17-272442, Exp. 8/16/2023; 17-272801, Exp. 8/22/2023; 17-273511, Exp. 9/4/2023; 17-273576, 17-273611, Exp. 9/5/2023; 17-274048, 17-274050, Exp. 9/12/2023.
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
- 5,259 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-1060-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.