Agency classClass IIOur severity:Severe FDA (Drugs)·D-290-2013·Announced 2013-05-01

FDA Recalls Triamcinolone Diacetate Injectable Due to Sterility Concerns

Axium Healthcare Pharmacy is recalling 172 vials of Triamcinolone Diacetate Injectable 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 and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Triamcinolone Diacetate Injectable manufactured by Axium Healthcare Pharmacy dba Balanced Solutions Compounding. The recall involves 172 vials (5 mL each) distributed to Colorado, Georgia, Michigan, and Puerto Rico. The agency classifies this as a Class II recall.

The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the facility's quality control processes as the reason for the action.

Consumers and healthcare providers who have received these products should stop using them and contact the recalling firm or their healthcare provider for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: Triamcinolone Diacetate 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 — Injectable Sterile Product
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