PlainRecalls
FDA Drug Moderate Class II Completed

T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Reported: June 1, 2022 Initiated: May 9, 2022 #D-0909-2022

Product Description

T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Reason for Recall

Lack of assurance of sterility.

Details

Units Affected
3312 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Location
Orlando, FL

Frequently Asked Questions

What product was recalled?
T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy. Units affected: 3312 vials.
Why was this product recalled?
Lack of assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2022. Severity: Moderate. Recall number: D-0909-2022.