T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vi...
FDA Recall #D-0909-2022 — Class II — May 9, 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.
Recalling Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy — Orlando, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3312 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Code Information
Lots: K41J09, K41I09 BUD: 11/9/2022; B24B22-22 BUD: 2/22/2023
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated