Recall of Injectable Methylcobalamin Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling injectable Methylcobalamin due to quality control issues affecting 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, and the hazard 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 all lots of sterile products compounded by the pharmacy that are not expired. The recall is due to concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The specific product identified in the recall notice is METHYCOBALAMIN, preservative free, 10mg/mL, injectable, 1 mL glass vial. The affected lot number is 20140729@16/1, with a discard date of 11/26/2014. The product was distributed in Oregon and Washington.
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 free, 10mg/mL, injectable, 1 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@16/1
- discard date: 11/26/2014
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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