Agency classClass IIOur severity:Severe FDA (Drugs)·D-1766-2015·Announced 2015-09-23

Compounded Tri-Mix Injectable Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Tri-Mix injectable products due to FDA inspection findings of GMP violations that may 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/sterility issues that could lead to adverse health consequences are categorized as Severe (Score 4), as they are not Class I (Critical) but represent a significant risk.

Plain-English summary

The Compounding Pharmacy of America is recalling 62 ml vials of Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen. The product was 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 and safety.

Patients who have received this medication should consult their healthcare provider for guidance on next steps. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded 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 (15)

All lots distributed between November 2014 and May 2015
01082015@10
7/7/2015
12192014@10
6/17/2015
12022014@4
5/31/2015
12302014@56
6/28/2015
01262015@84
7/25/2015
03302015@51
9/26/2015
05052015@83
11/1/2015

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 →

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Same hazard · sterility