PHENYLephrine 20 mg in 0 recalled over sterility concerns
- Recall date
- July 14, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- SCA Pharmaceuticals recalls PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 722…
- Recall number
- D-1030-2017
- FDA classification
- Class II
- Brand / firm
- SCA Pharmaceuticals
- Sold / distributed
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; product has the potential to leak.
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 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
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