FDA Recalls Papaverine HCL Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Papaverine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
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 and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for Papaverine HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vials. The product was 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. This recall includes all lots of sterile products compounded by the pharmacy that are not expired.
The affected product is distributed in Oregon and Washington. The specific lot number is 20140903@14/1.25, with a discard date of 10/18/2014. Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 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 #: 20140903@14/1.25
- discard date: 10/18/2014
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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