PlainRecalls
FDA Drug Moderate Class II Completed

Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Reported: June 1, 2022 Initiated: May 9, 2022 #D-0920-2022

Product Description

Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835

Reason for Recall

Lack of assurance of sterility.

Details

Units Affected
1287 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Location
Orlando, FL

Frequently Asked Questions

What product was recalled?
Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy. Units affected: 1287 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-0920-2022.