FDA Recalls Papaverine Injection Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine Mes/Prostaglandin injections 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 agency classification is FDA Class II. The hazard involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Papaverine HCL/Phentolamine Mes/Prostaglandin, 23mg/0.96mg/19.23mcg, injectable, 1.7 mL glass vials. The product is manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.
The recall is being conducted due to a lack of sterility assurance. According to the source text, all lots of sterile products compounded by the pharmacy that are not expired are affected. This action follows concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The affected product was distributed in Oregon and Washington. The specific lot number is 20140708@30, with a discard date of 12/2/2014. Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, 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 #: 20140708@30
- discard date: 12/2/2014
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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