FDA Recalls Injectable Papaverine HCL/Phentolamine/Prostaglandin Due to Sterility Concerns
Oregon Compounding Centers is recalling specific lots of injectable Papaverine HCL/Phentolamine/Prostaglandin 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection, fitting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for specific lots of PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The affected product is available in 1.25 mL or 1.7 mL glass vials. The recall covers lots distributed in Oregon and Washington with the following identifiers: Lot # 20140827@30 (discard date 10/11/2014), Lot # 20140910@28/1.7 (discard date 10/25/2014), and Lot # 20140917@2/1.25 (discard date 11/1/2014).
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 sterile products. This issue affects all lots of sterile products compounded by the pharmacy that are not expired.
Healthcare providers and patients in Oregon and Washington who have received or possess these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall.
The recalled product
- Product
- PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
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 #: 20140827@30
- discard date: 10/11/2014
- Lot #: 20140910@28/1.7
- discard date: 10/25/2014
- Lot #: 20140917@2/1.25
- discard date: 11/1/2014.
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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