Agency classClass IIOur severity:Severe FDA (Drugs)·D-1790-2015·Announced 2015-09-23

FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM Injectable nationwide due to FDA inspection findings of GMP violations that impact 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 significant quality issues like sterility assurance are categorized as Severe (Score 4).

Plain-English summary

The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable. The recall covers 802 ml of the product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations create a lack of assurance regarding the sterility of the product, potentially impacting its quality.

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

The recalled product

Product: Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility
gmp-violations

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 (13)

All lots distributed between November 2014 and May 2015
12182014@66
6/16/2015
01052015@51
7/4/2015
01192015@33
7/18/2015
02192015@9
8/18/2015
05042015@38
10/31/2015
04012015@63
9/28/2015

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

See all →

Critical
FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
Severe
FDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Severe
Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23

Same hazard · sterility