Alcohol Prep Pads recalled over sterility concerns
- Recall date
- September 5, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Simple Diagnostics, Inc. recalls Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Win…
- Recall number
- D-0134-2018
- FDA classification
- Class II
- Brand / firm
- Simple Diagnostics, Inc.
- Sold / distributed
- Product was distributed throughout the United States
Why it was recalled
Lack of Assurance of Sterility and cGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
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