FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.
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 source text identifies a lack of sterility assurance in an injectable drug, which presents a potential risk of serious infection. Per the rubric, FDA Class II recalls involving significant injury risks or hospitalization potential are classified as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Papaverine/Phentolamine/Prostaglandin injectable vials manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The affected product is a 1.7 mL glass vial containing 17.64mg Papaverine, 0.58mg Phentolamine, and 5.8mcg Prostaglandin. The specific lot number is 20140828@4/1.7, with a discard date of October 15, 2014.
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. This issue affects all lots of sterile products compounded by the pharmacy that have not expired.
The product was distributed in Oregon and Washington. Patients who have received this medication should contact their healthcare provider for guidance on next steps. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
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)
- Lot #: 20140828@4/1.7
- discard date: 10/15/2014
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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