SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial,...
FDA Recall #D-0901-2022 — Class II — May 9, 2022
Product Description
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; 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
874 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Code Information
Lots: L24D14, L24C14 BUD: 12/14/2022
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated