Fagron Compounding Services LLC dba Fagron Sterile Services recalls Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per packag…

Recall date

June 29, 2018

Source

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

Recall number

D-0910-2018

FDA classification

Class I

Brand / firm

Fagron Compounding Services LLC dba Fagron Sterile Services

Sold / distributed

Nationwide in the USA

Why it was recalled

Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.