LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine 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. NDC: 51552-1539-1
Reported: December 11, 2019 Initiated: October 31, 2019 #D-0533-2020
Product Description
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine 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. NDC: 51552-1539-1
Reason for Recall
Microbial contamination of non-sterile product.
Details
- Recalling Firm
- Fagron, Inc
- Units Affected
- 11,912 kits
- Distribution
- Nationwide
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine 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. NDC: 51552-1539-1. Recalled by Fagron, Inc. Units affected: 11,912 kits.
Why was this product recalled? ▼
Microbial contamination of non-sterile product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 11, 2019. Severity: Moderate. Recall number: D-0533-2020.
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