Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0482-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 1931 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Compounding Inc
Original FDA data
Every field from FDA enforcement report D-0482-2019, exactly as published.
Show all FDA fields
- City
- Conway
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 81982
- Address
- 1270 Dons Ln
- Code information
- Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.
- Postal code
- 72032-4753
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0482-2019
- Classification
- Class II
- Recalling firm
- US Compounding Inc
- Product quantity
- 1931 syringes
- Termination date
- Jan 24, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 24, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2019