FDA Recalls Copper Sulfate Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Copper Sulfate 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 an injectable product, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Copper (Sulf), 0.4 mg/mL, injectable, 20 mL glass vials. The recall involves 600 mL of product distributed in Oregon and Washington. The specific lot number is 20140919@21, with a discard date of 11/3/2014.
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 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 the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- COPPER (SULF), 0.4 mg/mL, injectable, 20 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 #: 20140919@21
- discard date: 11/3/2014
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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