FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Hydroxocobalamin (B12) injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated as Severe (4). While specific injury reports are not detailed in the text, the agency classification and the nature of the sterility risk in an injectable product align with the Severe criteria.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling Hydroxocobalamin-preservative free (B12), 1mg/mL, injectable, 2 mL glass vials. The recall involves 58 mL of product from Lot # 20140717@6, which had a discard date of 10/15/2014.
The recall was initiated due to a lack of sterility assurance. This issue stems from quality control procedures observed during a recent FDA inspection that present a potential risk to the sterility of the compounded sterile products.
The affected product was distributed in Oregon and Washington. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HYDROXOCOBALAMIN-preservative free (B12), 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 (2)
- Lot #: 20140717@6
- discard date: 10/15/2014
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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