Drug & medication recalls Moderate risk

EPINEPHrine 4 mg 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 EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medi…
Recall number
D-0931-2018
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

EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.

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