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Recall Observatory FDA recall evidence

Drug product

Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211

D-0252-2021

January 21, 2021

Class II

Product summary

Firm
Stanley Specialty Pharmacy Compounding and Wellness Center
Event
Event 87255
Status
Terminated
Classification
Class II
Quantity
4400 grams (44 jars)
Official record key
drug-enforcement:D-0252-2021

Official wording

Reason: Superpotent Drug. Lidocaine higher concentration than listed

Code information: Lot: 195789 Exp. Apr. 17 2021

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent