Recalls / Class II
Class IID-0005-2024
Product
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
- Affected lot / code info
- Lot: 17-275231, 17-275232, Exp. 10/2/2023; 17-275563, 17-275567, 17-275573, 17-275580, Exp. 10/8/2023; 17-275767, 17-275784, Exp. 10/10/2023;
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
- 3,384 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-0005-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.