Reported Dec 11, 2019 · Terminated
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4…
Fagron, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fagron, Inc · 2400 Pilot Knob Rd · Saint Paul, MN · 55120-1118
Is this the product you have?
- LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL)
- ContainsLETS
- Powders for GelLidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120
- NDC51552-1539-1
- Lot codes and dates
- Lot
- expiry
65 of 65 codes
18F25-U03-04429611/8/201918F25-U04-04429711/8/201918H22-U06-0452841/24/202018I24-U05-04585311/8/201918K06-U03-0470411/24/202018K06-U04-0470421/24/202018K27-U11-0474603/16/202018K28-U10-0475193/16/202019A06-U02-0481823/16/202019A06-U03-0481833/16/202019A16-U13-0483633/16/202019A21-U02-0485033/16/202019B10-U02-0487873/16/202019B14-U05-0487813/16/202019C05-U01-0491993/16/202019C05-U02-0492003/16/202019C11-U07-0494513/16/2020 19C25-U02-0487583/16/202019D07-U01-0498843/16/202019D07-U02-0498853/16/202019E09-U01-0502983/16/202019E23-U01-0507639/11/202019F16-U12-0000529/11/202019F16-U13-00005310/24/202019G07-U01-00035710/24/202019G07-U02-00035810/24/202019G21-U01-00093010/24/202019G21-U02-00093112/17/202019H01-U01-00117212/17/202019H01-U02-00117412/17/202019I03-U01-002019
- Amount recalled
- 11,912 kits
Where it was sold
- Nationwide
Why it was recalled
Microbial contamination of non-sterile product.
This product could cause temporary or reversible health problems — stop using it.
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