Agency classClass IIOur severity:Severe FDA (Drugs)·D-0149-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls TRIMIX Injectable Solution Due to Sterility Concerns

JD & SN Inc. is recalling TRIMIX injectable solution because the agency could not ensure the product remained sterile. Patients should stop using the medication and contact their healthcare provider.

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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be lower, regardless of whether specific injuries are reported in the text.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling TRIMIX, an injectable solution containing 30mg/1mg/10mcg of active ingredients. The recall was initiated because the company could not provide assurance of the sterility of the compounded drug. The affected product is available in 5 mL and 10 mL syringe sizes and is prescribed only.

The recall covers specific lots of the medication, including those with codes t12082014@33, t12012014@10, t11072014@5, t10202014@19, t08282014@10, t07282014@29, t01222015@18, and t02122015@33. The source text indicates that all sterile human compounded drugs within their expiry dates are affected by this lack of assurance. The distribution pattern for these products is listed as nationwide.

Patients who have received this medication should stop using it and contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: TRIMIX, injectable Solution, 30MG/1MG/10MCG, syringe sizes: 5 mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Manufacturer: JD & SN Inc., dba Moses Lake Professional Pharmacy
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 (8)

t12082014@33
t12012014@10
t11072014@5
t10202014@19
t08282014@10
t07282014@29
t01222015@18
t02122015@33

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy 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 101 products in this recall →

Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy

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