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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2

D-0594-2024

July 03, 2024

Class II

Product summary

Firm
TAILSTORM HEALTH INC
Event
Event 94930
Status
Ongoing
Classification
Class II
Quantity
12,525 10 mL vials
Official record key
drug-enforcement:D-0594-2024

Official wording

Reason: Subpotent Drug: reduced efficacy for epinephrine

Code information: Lot Number: 2311003, Expiration Date: 11/13/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent