FDA recall D-0929-2022

Olympia Compounding Pharmacy dba Olympia Pharmacy · Class II · drug

Product

Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10

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-0929-2022