PHENYLephrine 10 mg 10mg recalled over sterility concerns
- Recall date
- June 12, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Avella of Deer Valley, Inc. Store 38 recalls PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. F…
- Recall number
- D-0965-2018
- FDA classification
- Class II
- Brand / firm
- Avella of Deer Valley, Inc. Store 38
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
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