FDA Recalls Methycobalamin Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling specific lots of Methycobalamin injectable 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 an injectable product, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Methycobalamin, preservative free, 1mg/mL, injectable, 2 mL glass vial. The recall was initiated 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 affected product is distributed in Oregon and Washington. The specific lots subject to recall are Lot # 20140722@2/2 with a discard date of 1/18/2015, and Lot # 20140910@40/2 with a discard date of 3/9/2015. The total quantity involved is 516 mL.
Consumers and healthcare providers should stop using the affected lots and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- METHYCOBALAMIN, preservative free, 1mg/mL, injectable, 2 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 #: 20140722@2/2
- discard date: 1/18/2015
- Lot #: 20140910@40/2
- discard date: 3/9/2015.
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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