FDA recall D-1019-2019

Advanced Pharma Inc. · Class II · drug

Product

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

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-1019-2019