Agency classClass IIOur severity:Severe FDA (Drugs)·D-1720-2015·Announced 2015-09-23

FDA Recalls Tri-Mix Super Injectable Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Tri-Mix Super Injectable vials because FDA inspections found 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. Per the rubric, FDA Class II recalls involving potential sterility issues in injectable products are assigned a score of 4 (Severe) due to the risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

The Compounding Pharmacy of America is recalling Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen. The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring between July 2015 and October 2015.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on return or disposal. The FDA classifies this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Compounded Drug
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 (16)

All lots distributed between November 2014 and May 2015
01202015@30
7/19/2015
01262015@22
7/25/2015
02092015@14
7/1/2015
02192015@12
8/18/2015
03202015@86
9/16/2015
03232015@25
9/19/2015
04282015@14
10/25/2015
04282015@18

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