EDTA DISODIUM 15% recalled over sterility concerns
- Recall date
- May 13, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Medaus, Inc. recalls EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
- Recall number
- D-1182-2016
- FDA classification
- Class II
- Brand / firm
- Medaus, Inc.
- Sold / distributed
- U.S. Nationwide, Japan, and New Zealand.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
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