Recalls / Class II
Class IID-0482-2019
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.
- Affected lot / code info
- Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.
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.
Recalling firm
- Firm
- US Compounding Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1270 Dons Ln, N/A, Conway, Arkansas 72032-4753
Distribution
- Quantity
- 1931 syringes
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-01-24
- FDA classified
- 2019-02-08
- Posted by FDA
- 2019-02-20
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0482-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.