FDA Recalls Pyridoxine HCL Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Pyridoxine HCL 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Pyridoxine HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vials. The product is manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds, located in Wilsonville, Oregon.
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 of the compounded sterile products. The recall covers all lots of sterile products compounded by the pharmacy that are not expired.
The affected lots include Lot # 20140715@18 with a discard date of 10/13/2014, and Lot # 20140917@18 with a discard date of 12/16/2014. The total quantity involved is 660 mL. The product was distributed in Oregon and Washington. Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — 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 (4)
- Lot #: 20140715@18
- discard date: 10/13/2014
- Lot #: 20140917@18
- discard date: 12/16/2014
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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