FDA recall D-1032-2019

Product

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 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-1032-2019