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Recall Observatory FDA recall evidence

Drug product

lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1

D-0004-2024

September 21, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 93103
Status
Terminated
Classification
Class II
Quantity
1,992 5 mL syringes
Official record key
drug-enforcement:D-0004-2024

Official wording

Reason: Lack of assurance of sterility:

Code information: Lot: 17-275788, Exp. 10/10/2023; 17-275872, Exp. 10/11/2023; 17-275922, Exp. 10/12/2023; 17-275972, 17-275973, Exp. 10/15/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility