Midazolam Benzodiazepine 50 mg/ Injectable Solution recalled over sterility concerns

Recall date

March 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Advanced Pharma Inc. recalls Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile sin…

Recall number

D-1019-2019

FDA classification

Class II

Brand / firm

Advanced Pharma Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404