Agency classClass IIOur severity:High FDA (Drugs)·D-0899-2022·Announced 2022-06-01

Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns

Olympia Compounding Pharmacy recalled 1,710 vials of RE-2 injectable medication due to lack of assurance of sterility. Affected vials were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.

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: FDA Class II injectable medication recall with no reported illnesses or hospitalizations. Meets rubric criterion for High severity: risk-of-harm product (injectable medication) where injury has not yet been reported. Sterility is a critical attribute for injectables.

Plain-English summary

Olympia Compounding Pharmacy is recalling RE-2 injectable medication containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and Alprostadil 300 mcg/mL due to lack of assurance of sterility. The recall affects 1,710 vials (NDC 73198-0016-03 and NDC 73198-0016-10, lots K24B09 and K24C09).

The affected medication was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. Lack of assurance of sterility is a serious concern for injectable medications, as non-sterile products intended for injection can lead to bacterial or fungal infection at the injection site and systemically.

Healthcare providers should immediately stop using affected lots and contact patients who may have received injections from these vials. Patients who received this medication should consult their healthcare provider to discuss any concerns or symptoms.

The recalled product

Product: RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
Affected units: 1,710

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 (2)

Lots: K24B09
K24C09 BUD: 11/09/2022

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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