FDA recall D-1024-2019

Advanced Pharma Inc. · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2019-03-13
Report date: 2019-03-27
Termination date: 2020-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1024-2019