Agency classClass IIOur severity:Severe FDA (Drugs)·D-403-2014·Announced 2014-01-15

FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns

The FDA is recalling all lots of Super Triple Mix Injectable from The Compounding Center at Blue Ridge due to quality control concerns regarding sterility assurance.

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, which corresponds to a 'Severe' rating under the rubric. The hazard involves a lack of assurance of sterility in injectable products, which poses a significant risk of infection or serious injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Super Triple Mix Injectable, also known as Dr Lentz Triple Rx Injectable, Dr Kane's Super Triple Rx Injectable, and Dr Tortora's Super Triple Rx Injectable. The product is a 5 mL vial, prescription-only injectable manufactured by The Compounding Center at Blue Ridge in Raleigh, North Carolina. All lots of sterile products compounded by the pharmacy within their expiry dates are subject to this recall.

The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, the agency cited a lack of assurance of sterility for the affected products.

Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product: Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Manufacturer: Compounding Centre At Blue Ridge
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 3

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

See all →

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Same hazard · sterility