Agency classClass IIOur severity:Severe FDA (Drugs)·D-0147-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Trimix Injectable Solution Due to Sterility Concerns

JD & SN Inc. is recalling 15 syringes of Trimix injectable solution because the FDA could not assure the sterility of the compounded drug.

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. According to the rubric, an FDA Class II recall involving a sterile injectable drug where sterility assurance is lacking is categorized as Severe (Score 4), as it poses a significant risk of infection or injury.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 15 syringes of TRIMIX, injectable Solution (15MG/.5MG/5MCG/ML, 10mL). The recall was initiated because the U.S. Food and Drug Administration (FDA) could not assure the sterility of the sterile human compounded drugs within their expiry dates.

The affected product was distributed nationwide. The recall covers specific lots with codes including t12192014@8, t12122014@20, t11212014@2, t10232014@25, t09292014@4, t09162014@13, t08082014@19, t06082015@2, t05042015@2, t04082015@21, t04022015@24, t03232015@5, t02092015@25, and t01222015@9.

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

The recalled product

Product: TRIMIX, injectable Solution, 15MG/.5MG/5MCG/ML, 10mL syringe, 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-failure
infection-risk
Affected units: 15

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 (14)

t12192014@8
t12122014@20
t11212014@2
t10232014@25
t09292014@4
t09162014@13
t08082014@19
t06082015@2
t05042015@2
t04082015@21
t04022015@24
t03232015@5
t02092015@25
t01222015@9.

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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Same hazard · sterility failure