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RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi...

FDA Recall #D-0898-2022 — Class II — May 9, 2022

Recall #D-0898-2022 Date: May 9, 2022 Classification: Class II Status: Completed

Product Description

RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; 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

482 vials

Distribution

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Code Information

Lots: B24E09-22 BUD: 02/09/2023; B24F09-22 BUD: 02/09/2023

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.

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