FDA recall D-0910-2018

Product

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.

Reason for recall

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-06-29

Report date

2018-07-11

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wichita, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0910-2018