Data Foundry

Drug recalls 2018

Alcohol Prep Pads — Class II drug recall D-0134-2018

Terminated recall by Simple Diagnostics, Inc., reported 2018-01-03, distributed nationwide. Lack of Assurance of Sterility and cGMP Deviations

Recall numberD-0134-2018
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSimple Diagnostics, Inc., Coral Springs, FL, United States
Recall initiated2017-09-05
Classified2017-12-26
Reported by FDA2018-01-03
Terminated2018-09-19
DistributedNationwide (US)
Quantity150,250 alcohol
Reason classessterility, cgmp
NDC98302-0001-05
Lot numbersSD2070420601, SD2070420925, SD2070421201
Expiration dates2019-09, 2019-12

Product

Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05

Reason for recall

Lack of Assurance of Sterility and cGMP Deviations

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-0134-2018. 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.