QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose...
FDA Recall #D-0947-2022 — Class II — May 9, 2022
Product Description
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0018-10.
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
619 vials
Distribution
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Code Information
Lot: K24D15 BUD: 11/15/2022
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.