FDA Recalls Injectable Methycobalamin Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling injectable Methycobalamin vials due to quality control issues that present a potential risk to sterility assurance.
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 Methycobalamin, a preservative-containing injectable solution manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall involves 10 mL glass vials containing 1 mg/mL of Methycobalamin. The total quantity affected is 1,320 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 assurance of the compounded sterile products. The recall covers all lots of sterile products compounded by the pharmacy that are not expired.
The affected product was distributed in Oregon and Washington. Specific lot numbers and discard dates are listed in the recall documentation. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
- Hazard
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 (7)
- Lot #: 20140715@2
- discard date: 10/13/2014
- Lot #: 20140724@10
- discard date: 10/22/2014
- Lot #: 20140812@14
- discard date: 11/1/2014
- Lot #: 20140826@5
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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