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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Category
- Drug — Injectable Compounded
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
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.
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