FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling 117 vials of Chorionic Gonadotropin 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 a sterile injectable product, which poses a significant risk of serious injury.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling 117 vials of Chorionic Gonadotropin, 5000 Units, sterile powder for reconstitution. The affected lots are 20140909@5 (discard date 3/8/2015) and 20140728@57 (discard date 1/14/2015). The product was distributed in Oregon and Washington.
The recall was initiated due to a lack of sterility assurance. FDA inspection observations identified concerns associated with quality control procedures that present a potential risk to sterility assurance for all lots of sterile products compounded by the pharmacy that are not expired.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CHORIONIC GONADOTROPIN, 5000 Units, sterile powder for reconstitution, glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Affected units
- 117
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 #: 20140909@5
- discard date: 3/8/2015
- Lot #: 20140728@57
- discard date: 1/14/2015.
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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