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
Product summary
- 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
Labeling: Incorrect or Missing