EPHEDrine Sulfate 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 ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose…

Recall number

D-0964-2018

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

ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61