FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Hydroxocobalamin 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' rating under the rubric, particularly given the risk of sterility failure in an injectable product.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Hydroxocobalamin (Vitamin B12) injectable vials manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall involves 10 mL glass vials containing 1 mg/mL of Hydroxocobalamin with preservative. The specific lot number is 20140729@18, with a discard date of October 27, 2014. The total quantity affected is 570 mL.
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 the sterility of the compounded products. This issue affects all lots of sterile products compounded by the pharmacy that have not expired.
The affected products were distributed in Oregon and Washington. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions on how to handle the medication.
The recalled product
- Product
- HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 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 (2)
- Lot #: 20140729@18
- discard date: 10/27/2014
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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