CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
Lets Gel Kit Convenience Pack (To prepare Lets Gel) recalled by Fagron
Fagron is recalling Lets Gel Kit Convenience Pack (To prepare Lets Gel), Contains: Lets Powders for Gel, distributed nationwide in the US. The recall was initiated on 31 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0533-2020
- FDA event ID
- 84179
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Oct 2019
- FDA classified
- 29 Nov 2019
- Reported
- 11 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 31 Oct 2019 | Recall initiated by company | |
| 29 Nov 2019 | Classified by FDA | +29 days |
| 11 Dec 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of non-sterile product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Microbial contamination of non-sterile product.
Which lots are affected?
Lot, expiry: 18F25-U03-044296, 11/8/2019; 18F25-U04-044297, 11/8/2019; 18H22-U06-045284, 1/24/2020; 18I24-U05-045853, 11/8/2019; 18K06-U03-047041, 1/24/2020; 18K06-U04-047042, 1/24/2020; 18K27-U11-047460, 3/16/2020; 18K28-U10-047519, 3/16/2020; 19A06-U02-048182, 3/16/2020; 19A06-U03-048183, 3/16/2020; 19A16-U13-048363, 3/16/2020; 19A21-U02-048503, 3/16/2020; 19B10-U02-048787, 3/16/2020; 19B14-U05-048781, 3/16/2020; 19C05-U01-049199, 3/16/2020; 19C05-U02-049200, 3/16/2020; 19C11-U07-049451, 3/16/2020 19C25-U02-048758, 3/16/2020; 19D07-U01-049884, 3/16/2020; 19D07-U02-049885, 3/16/2020; 19E09-U01-050298, 3/16/2020; 19E23-U01-050763, 9/11/2020; 19F16-U12-000052, 9/11/2020; 19F16-U13-000053, 10/24/2020; 19G07-U01-000357, 10/24/2020; 19G07-U02-000358, 10/24/2020; 19G21-U01-000930, 10/24/2020; 19G21-U02-000931, 12/17/2020; 19H01-U01-001172, 12/17/2020; 19H01-U02-001174, 12/17/2020; 19I03-U01-002019, 2/4/2021; 19I03-U02-002020, 2/4/2021; 19I03-U03-002021, 12/17/2020
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fagron
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin 150 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 2 BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 500 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |