Renacidin Solution Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Renacidin solution 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 a sterile product, which poses a significant risk of infection or serious injury.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling 900 mL of CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation. The product is packaged in 30 mL plastic syringes and is a prescription medication. The recall involves Lot # 20140908@2 with a discard date of 10/23/2014.
The recall was initiated due to a lack of sterility assurance. This decision follows concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection. The agency has classified this recall as Class II.
The product was distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, 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 #: 20140908@2
- discard date: 10/23/2014
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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