Edetate Disodium150mg/mL PFV recalled over sterility concerns
- Recall date
- June 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- RXQ Compounding LLC recalls Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 707…
- Recall number
- D-1654-2019
- FDA classification
- Class II
- Brand / firm
- RXQ Compounding LLC
- Sold / distributed
- Nationwide USA
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
Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0934-11
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