FDA recall D-0899-2022

Product

RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Reason for recall

Lack of assurance of sterility.

Distribution

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Key facts

Status

Completed

Initiation date

2022-05-09

Report date

2022-06-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0899-2022