FDA Recalls Compounded Injectable Drug Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling specific lots of a compounded injectable drug 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 recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific lots of PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial. The product was compounded by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.
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. The recall covers all lots of sterile products compounded by the pharmacy that have not expired.
The affected lots are distributed in Oregon and Washington. The specific lot numbers and discard dates are: Lot # 20140722@16/1.7 (discard date 12/3/2014) and Lot # 20140728@43/2 (discard date 12/3/2014). Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- PAPAVERINE HCL/PHENTOLAMINE/ALPROSTADIL, 21.82mg/0.91mg/45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Compounded 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 (4)
- Lot #: 20140722@16/1.7
- discard date: 12/3/2014
- Lot #: 20140728@43/2
- discard date: 12/3/2014.
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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