Agency classClass IIOur severity:Severe FDA (Drugs)·D-0185-2015·Announced 2014-11-12

FDA Recalls Dexamethasone Injectable Vials Due to Sterility Concerns

Oregon Compounding Centers is recalling Dexamethasone 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 with potential for significant injury or hospitalization (implied by sterility failure in injectables) are rated as Severe (4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Dexamethasone (as Sod Phos), 24 mg/mL, injectable, 1 mL glass vials manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The recall involves all lots of sterile products compounded by the pharmacy that have not expired.

The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These issues were observed during a recent FDA inspection of the facility. The specific lot number 20140903@10 with a discard date of 10/18/2014 is identified in the product information, but the recall scope includes all non-expired sterile lots from the pharmacy.

The affected products were distributed in Oregon and Washington. Consumers and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: DEXAMETHASONE (AS SOD PHOS), 24 mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable Sterile Compounded
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 #: 20140903@10
discard date: 10/18/2014

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