Agency classClass IIOur severity:Severe FDA (Drugs)·D-0215-2015·Announced 2014-11-12

FDA Recalls Papaverine, Phentolamine, and Alprostadil Injectable Due to Sterility Concerns

Oregon Compounding Centers is recalling specific lots of a sterile injectable drug due to quality control issues that may compromise sterility.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The lack of sterility assurance in an injectable product poses a significant risk of infection, aligning with the 'Severe' criteria for significant injury potential.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for specific lots of PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial. The product is compounded by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.

The recall is being conducted due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility of the compounded products. The affected lots are identified by the following lot numbers and discard dates: 20140910@48/1.25 (discard 10/25/2014), 20140911@11/1.25 (discard 10/26/2014), and 20140916@17/1.25 (discard 10/31/2014). The product was distributed in Oregon and Washington.

Consumers and healthcare providers should check their inventory for these specific lot numbers. If the product is found, it should be discontinued and returned to the pharmacy or manufacturer for disposal. Patients who have received this medication should contact their healthcare provider for guidance.

The recalled product

Product: PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable Compounded
Hazard: sterility-failure
infection-risk

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 (6)

Lot #: 20140910@48/1.25
discard date: 10/25/2014
Lot #: 20140911@11/1.25
discard date: 10/26/2014
Lot #: 20140916@17/1.25
discard date: 10/31/2014.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

See all →

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Same hazard · sterility failure