NORepiNEPHrine Bitartrate 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 NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston…
- Recall number
- D-0959-2018
- 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
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
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