Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0720-2022·Announced 2022-03-30

Compounded injectable Formula F9 recalled for insufficient potency

Olympia Compounding Pharmacy recalled Formula F9, a compounded injectable medication, because the product was sub-potent with insufficient active ingredient. The recall affected 493 vials distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall for sub-potency, a quality issue affecting product efficacy. This is a voluntary manufacturer-initiated recall, consistent with Class III recalls which are typically scored 1-2. The source text does not report deaths, serious injuries, or illnesses.

Plain-English summary

Olympia Compounding Pharmacy is recalling Formula F9, a multi-dose injectable medication containing Papaverine, Phentolamine, PGE, and Atropine. The recall was initiated on March 8, 2022.

The recall was issued because the product was determined to be sub-potent, meaning it contains insufficient amounts of its active ingredients compared to the labeled specification.

The affected lot (D41C19, expiring April 19, 2022) consisted of 493 vials distributed nationwide in the USA, including Puerto Rico. This was a voluntary recall initiated by the manufacturer.

Patients or healthcare providers who have this medication should consult with their healthcare provider to determine if the medication they received was affected and whether any follow-up is needed. The recall was completed on October 4, 2023.

The recalled product

Product: Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl…
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable / Compounded
Hazard: sub-potent
Affected units: 493

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: D41C19 Exp. 4/19/22

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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