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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84179

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 31, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fagron, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0533-2020
Recall number
D-0533-2020
Initiated
October 31, 2019
Classification
Class II
Status
Terminated
Recalling firm
Fagron, Inc
Quantity
11,912 kits

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of non-sterile product.

Code information

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

Distribution pattern

Nationwide

Field note

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