Agency classClass IIOur severity:Severe FDA (Drugs)·D-0199-2015·Announced 2014-11-12

FDA Recalls Hydroxocobalamin Injectable Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling Hydroxocobalamin 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an injectable product.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Hydroxocobalamin (Vitamin B12) injectable vials manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall involves 10 mL glass vials containing 1 mg/mL of Hydroxocobalamin with preservative. The specific lot number is 20140729@18, with a discard date of October 27, 2014. The total quantity affected is 570 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 of the compounded products. This issue affects all lots of sterile products compounded by the pharmacy that have not expired.

The affected products were distributed in Oregon and Washington. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions on how to handle the medication.

The recalled product

Product: HYDROXOCOBALAMIN- preservative (B12), 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable
Hazard: sterility-failure
infection-risk

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@18
discard date: 10/27/2014

Distribution

Distributed in 2 states:

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.

See all 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

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Same hazard · sterility failure