Agency classClass IIOur severity:High FDA (Drugs)·D-0947-2022·Announced 2022-06-01

Compounded Injectable Medication Recalled for Lack of Sterility Assurance

Olympia Compounding Pharmacy is recalling QM-2, a compounded multi-dose injectable medication, because the manufacturer cannot assure the product's sterility. The recall affects 619 vials distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile injectable product with lack of assurance of sterility. No illnesses or injuries have been reported. The hazard is significant but unconfirmed, warranting a High severity rating.

Plain-English summary

Olympia Compounding Pharmacy is recalling QM-2, a prescription compounded multi-dose injectable medication. The product contains papaverine, phentolamine, alprostadil, and atropine. The recall was initiated because the manufacturer could not assure the product's sterility.

Approximately 619 vials of QM-2 with Lot K24D15 and a beyond-use date of November 15, 2022, were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.

Patients should not use this product and should contact their healthcare provider or pharmacy for information about alternative medications.

The recalled product

Product: 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.
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Compounded Injectable
Hazard: sterility
contamination
Affected units: 619

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot: K24D15 BUD: 11/15/2022

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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