Recalls / Class II
Class IID-0007-2024
Product
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
- Affected lot / code info
- Lot: 17-275152, 17-275154, 17-275155, 17-275156, 17-275163, Exp. 10/1/2023; 17-275234, 17-275236, 17-275251, 17-275268, 17-275270, 17-275277, Exp. 10/2/2023; 17-275283, 17-275294, 17-275313, Exp. 10/3/2023; 17-275469, 17-275471, 17-275473, 17-275480, 17-275481, 17-275482, 17-275483, 17-275484, 17-275485, 17-2754990, 17-2754991, 17-2754993, Exp. 10/4/2023; 17-275558, 17-275654, 17-275667, Exp. 10/8/2023; 17-275722, 17-275737, Exp. 10/9/2023; 17-275768, 17-275804, 17-275805, Exp. 10/10/2023; 17-275847, 17-275849, 17-275857, 17-275882, Exp. 10/11/2023; 17-275923, Exp. 10/12/2023; 17-275983, 17-275984, Exp. 10/15/2023; 17-276123, Exp. 10/17/2023; 17-276125, 17-276126, Exp. 10/18/2023
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
- 19,510 10 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-0007-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.