Recall of Injectable Methycobalamin Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling specific lots of injectable Methycobalamin 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 the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death if administered.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of Methycobalamin, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vials. The recall involves 119 0.3 mL vials and 106 1 mL vials distributed in Oregon and Washington.
The recall was initiated due to a lack of sterility assurance. FDA inspection observations regarding quality control procedures presented a potential risk to the sterility of the compounded sterile products. The affected lots have specific discard dates ranging from January 14, 2015, to March 11, 2015.
Consumers and healthcare providers should stop using the affected lots immediately. The specific lot numbers and discard dates are listed in the recall documentation. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
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 (9)
- Lot #: 20140718@2/0.3
- discard date: 1/14/2015
- Lot #: 20140808@4/0.3
- discard date: 2/4/2015
- Lot #: 20140902@36/1
- discard date: 3/1/2015
- Lot #: 20140902@37/0.3
- Lot #: 20140912@22/1
- discard date: 3/11/2015.
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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