September 2017 FDA Recall Drug by Simple Diagnostics, Inc.
D-0134-2018 - Lack of Assurance of Sterility and cGMP Deviations

This Class II drug recall was voluntarily initiated by Simple Diagnostics, Inc. on September 5, 2017 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility and cgmp deviations. The product was distributed in Product was distributed throughout the United States and the recall is currently terminated.

Recall Number: D-0134-2018

Reason for Recall
Lack of Assurance of Sterility and cGMP Deviations
Initiated
09-05-2017
Reported
01-03-2018
Quantity
150,250 alcohol pads

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Simple Diagnostics, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# SD2070420925 Exp. Date 09/2019, and
Lot# SD2070421201 and
Lot# SD2070420601, Exp. Date 12/2019