Agency classClass IIOur severity:Severe FDA (Drugs)·D-0210-2015·Announced 2014-11-12

FDA Recalls Compounded Injectable Drug Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling specific lots of a compounded injectable drug due to quality control issues affecting sterility assurance.

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 and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific lots of PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial. The product was compounded by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.

The recall was initiated 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 recall covers all lots of sterile products compounded by the pharmacy that have not expired.

The affected lots are distributed in Oregon and Washington. The specific lot numbers and discard dates are: Lot # 20140722@16/1.7 (discard date 12/3/2014) and Lot # 20140728@43/2 (discard date 12/3/2014). Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product: PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Compounded Injectable
Hazard: sterility-assurance
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 (4)

Lot #: 20140722@16/1.7
discard date: 12/3/2014
Lot #: 20140728@43/2
discard date: 12/3/2014.

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

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Same hazard · sterility assurance