Neostigmine Methylsulfate Injection Solution 5 mg/ 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 Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, N…

Recall number

D-1024-2019

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

Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404