Agency classClass IIOur severity:Severe FDA (Drugs)·D-1798-2015·Announced 2015-09-23

FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Tri-Mix ST9A injectable products due to FDA inspection findings of GMP violations that may affect sterility.

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 adverse health consequences (such as sterility issues in injectables) are categorized as Severe.

Plain-English summary

The Compounding Pharmacy of America is recalling 112 ml vials of Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable. The recall was initiated following an FDA inspection that identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, creating a lack of assurance regarding the product's sterility.

The affected lots were distributed nationwide between November 2014 and May 2015. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers who have purchased or received this product should stop using it and contact The Compounding Pharmacy of America or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product: Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility
gmp-violation

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 distributed between November 2014 and May 2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility