Agency classClass IIOur severity:Severe FDA (Drugs)·D-285-2013·Announced 2013-05-01

FDA Recalls Quadmix Custom Injectable Due to Sterility Assurance Concerns

Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance and quality control concerns.

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 hospitalization or significant injury are rated as Severe (4). Lack of sterility assurance in injectable products poses a risk of serious infection.

Plain-English summary

Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling all lots of Quadmix Custom Injectable Balanced Solutions. The recall is being conducted because the compounding pharmacy lacked assurance of sterility for the products it compounded, repackaged, and distributed. The recall is also driven by concerns associated with the pharmacy's quality control processes.

The affected product consists of 3 vials (10 mL vials) of Quadmix Custom Injectable. The recall covers all lots of this product. The products were distributed in Colorado, Georgia, Michigan, and Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm 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: Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Manufacturer: Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Category: Drug — Compounded 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 (1)

ALL Lots

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 26 recalled by Axium Healthcare Pharmacy dba Balanced Solutions Compounding 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 26 products in this recall →

Same manufacturer · Axium Healthcare Pharmacy dba Balanced Solutions Compounding

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Same hazard · sterility failure