The Recall Desk
SevereFDA (Drugs)·D-270-2013·Announced 2013-05-01

Axium Healthcare Recalls TriMix Injectable Due to Sterility Concerns

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

What this means for you

Illness, injury, or structural failure has been reported. 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 infection associated with non-sterile injectable products.

Plain-English summary

Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling 380 vials of TriMix Standartd (PGE Stock Sol'n) Injectable. The recall involves 5 mL and 10 mL vials distributed to Colorado, Georgia, Michigan, and Puerto Rico.

The recall was initiated because of 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 who have purchased or received this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

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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