LETS GEL KIT Convenience Pack — Class II drug recall D-0533-2020
Terminated recall by Fagron, Inc, reported 2019-12-11, distributed nationwide. Microbial contamination of non-sterile product.
| Recall number | D-0533-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fagron, Inc, Saint Paul, MN, United States |
| Recall initiated | 2019-10-31 |
| Classified | 2019-11-29 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 11,912 kits |
| Reason classes | microbial contamination, sterility |
| NDC | 51552-1539-01 |
| Lot numbers | 18F25-U03-044296, 18F25-U04-044297, 18H22-U06-045284, 18I24-U05-045853, 18K06-U03-047041, 18K06-U04-047042, 18K27-U11-047460, 18K28-U10-047519, 19A06-U02-048182, 19A06-U03-048183, 19A16-U13-048363, 19A21-U02-048503, 19B10-U02-048787, 19B14-U05-048781, 19C05-U01-049199, 19C05-U02-049200, 19C11-U07-049451, 19C25-U02-048758, 19D07-U01-049884, 19D07-U02-049885, 19E09-U01-050298, 19E23-U01-050763, 19F16-U12-000052, 19F16-U13-000053, 19G07-U01-000357, 19G07-U02-000358, 19G21-U01-000930, 19G21-U02-000931, 19H01-U01-001172, 19H01-U02-001174, 19I03-U01-002019, 19I03-U02-002020, 19I03-U03-002021 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0533-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.