FDA recall D-0721-2022

Product

T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

Reason for recall

Super Potent

Distribution

Nationwide in the USA including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2022-03-08

Report date

2022-03-30

Termination date

2023-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0721-2022