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D-0482-2019 Class II Terminated

Recalled by US Compounding Inc — Conway, AR

FDA drug recall D-0482-2019 was initiated by US Compounding Inc on Jan 24, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jan 24, 2020). Affected quantity: 1931 syringes.

Recall Details

Product Type: Drugs
Report Date: Feb 20, 2019
Initiation Date: Jan 24, 2019
Termination Date: Jan 24, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1931 syringes

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA.

Code Information

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0482-2019
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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