FDA Recalls DMPS Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling DMPS 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 infection.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling DMPS-preservative free, 50 mg/mL, injectable, 5 mL glass vials. The recall involves specific lots with discard dates in October and November 2014. The product was distributed in Oregon and Washington.
The recall is being conducted 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 assurance of sterile products compounded by the pharmacy. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the affected lots immediately. The specific lot numbers are 20140724@24/5, 20140724@25, and 20140826@12. Patients who have received these products should contact their healthcare provider for guidance.
The recalled product
- Product
- DMPS-preservative free, 50 mg/mL, injectable, 5 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 (5)
- Lot #: 20140724@24/5
- discard date: 10/22/2014
- Lot #: 20140724@25
- Lot #: 20140826@12
- discard date: 11/24/2014.
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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