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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1

D-0006-2024

September 21, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 93103
Status
Terminated
Classification
Class II
Quantity
3,081 syringes
Official record key
drug-enforcement:D-0006-2024

Official wording

Reason: Lack of assurance of sterility:

Code information: Lot: 17-275323, 17-275345, Exp. 10/3/2023; 17-275642, 17-275643, 17-275671, Exp. 10/8/2023; 17-275675, 17-275677, Exp. 10/9/2023; 17-276188, Exp. 10/18/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility