Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0722-2022·Announced 2022-03-30

FDA recalls SB-4 compounded injection nationwide for below-strength potency

SB-4 compounded injection is being recalled nationwide because it contains less active ingredient than labeled. Olympia Compounding Pharmacy initiated this voluntary recall affecting 1,032 vials.

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: This is an FDA Class III recall of a sub-potent compounded medication with no reported illnesses or injuries. The issue is a quality/potency defect rather than a direct safety hazard, and the recall was voluntary and firm-initiated.

Plain-English summary

SB-4 is a compounded injectable medication containing papaverine, phentolamine, and alprostadil. Olympia Compounding Pharmacy initiated a voluntary recall because the product was found to be sub-potent—containing less active ingredient than specified on the label.

The recall affects 1,032 vials in two sizes (5 mL and 10 mL multi-dose vials). The affected lots are E41C18 and E41D18, both expiring May 18, 2022. Distribution was nationwide in the United States, including Puerto Rico.

Patients using this medication should contact their healthcare provider to discuss treatment alternatives or adjustments. The recall was classified as FDA Class III.

The recalled product

Product: SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5%…
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Compounded Injectable
Hazard: sub-potency
Affected units: 1,032

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: a) E41C18 Exp. 5/18/22
b) E41D18 Exp. 5/18/22

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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