FDA Recalls Compounded Omnipaque Injectable Due to Sterility Concerns
Oregon Compounding Centers is recalling compounded Omnipaque injectable vials 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 the hazard involves a lack of sterility assurance in an injectable product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of compounded OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vials. The recall is being conducted due to concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The affected product is a prescription sterile injectable solution. The recall covers all lots of sterile products compounded by the pharmacy that are not expired. The specific lots identified include Lot # 20140711@1, Lot # 20140814@22, and Lot # 20140815@13. The total quantity involved is 680 mL.
The product was distributed in Oregon and Washington. Consumers and healthcare providers should check their inventory for these specific lot numbers and discard dates. If you have this product, contact your healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- OMNIPAQUE, 300mgI/mL, injectable, 2 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 (6)
- Lot #: 20140711@1
- discard date: 1/7/2015
- Lot #: 20140814@22
- discard date: 2/10/2015
- Lot #: 20140815@13
- discard date: 2/11/2015.
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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