Agency classClass IIOur severity:Severe FDA (Drugs)·D-572-2013·Announced 2013-06-12

Tri-Mix Injections Recalled Due to Sterility Assurance Concerns

The Compounding Shop is recalling Tri-Mix Injections because FDA inspections raised concerns about quality control and 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

The Compounding Shop, Inc. is recalling Tri-Mix Injections in 5 mL and 10 mL vials. The product contains Alprostadil, Phentolamine, and Papaverine and was compounded in St. Petersburg, Florida. The recall involves 4 vials of 5 mL and 22 vials of 10 mL.

The recall was initiated because FDA inspection findings resulted in concerns regarding quality control processes and the assurance of sterility. The agency classified this as a Class II recall. The affected lots were distributed in Florida, California, Minnesota, and Maine.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product: Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Manufacturer: THE COMPOUNDING SHOP, INC.
Category: Drug — Compounded Injectable
Hazard: sterility
infection

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 25 recalled by THE COMPOUNDING SHOP, INC. 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 25 products in this recall →

Same manufacturer · THE COMPOUNDING SHOP, INC.

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