The Recall Desk
SevereFDA (Drugs)·D-401-2014·Announced 2014-01-15

Triple Mix Injectable Recalled for Lack of Sterility Assurance

The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable due to quality control concerns identified during an FDA inspection.

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 and involves a lack of assurance of sterility in injectable products, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable. The product is also known by several other names, including Dr Ungers Triple Rx, Dr Tortora's Triple Rx, and Dr Bennett's Triple Rx. The recall covers all lots of sterile products compounded by the pharmacy within their expiry dates.

The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. The specific hazard cited is a lack of assurance of sterility. The agency classification for this recall is Class II.

The recall is distributed in North Carolina. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ri
Affected units
92

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 1 state:

Part of a larger recall action

This product is one of 5 recalled by Compounding Centre At Blue Ridge 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 5 products in this recall →

Same manufacturer · Compounding Centre At Blue Ridge

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