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Recall Observatory FDA recall evidence

Drug product

LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.

D-0482-2019

January 24, 2019

Class II

Product summary

Firm
US Compounding Inc
Event
Event 81982
Status
Terminated
Classification
Class II
Quantity
1931 syringes
Official record key
drug-enforcement:D-0482-2019

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.

Code information: Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing