Alprostadil Injectable Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Alprostadil 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 if contaminated.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Alprostadil, 10 mcg/mL, injectable, 1.7 mL glass vials. The recall is being conducted due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection.
The recall includes all lots of sterile products compounded by the pharmacy that are not expired. The specific lot identified in the recall notice is Lot # 20140913@10 with a discard date of 10/28/2014. The affected products were distributed in Oregon and Washington.
Consumers and healthcare providers should check their inventory for this product and stop using it if it matches the recalled description. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.
The recalled product
- Product
- ALPROSTADIL, 10 mcg/mL, injectable, 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 (2)
- Lot #: 20140913@10
- discard date 10/28/2014
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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