FDA recall D-1020-2019

Product

Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 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-1020-2019