Agency classClass IIOur severity:Severe FDA (Drugs)·D-0128-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

JD & SN Inc. is recalling 91 vials of compounded testosterone pellets because the FDA cannot assure the sterility of the product.

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, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile compounded drugs where sterility assurance is lacking.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 91 vials of Testosterone, Pellet, 112 mg, Rx only. The recall is being conducted because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the sterile human compounded drugs within their expiry dates.

The affected product was distributed nationwide. The recall covers specific lots identified by codes such as t12192014@18 and 11052014@20. The source text does not specify the exact number of units distributed per lot or the total number of patients affected.

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 FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: TESTOSTERONE, Pellet, 112 mg, 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 Sterile Drug
Hazard: sterility
infection
Affected units: 91

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 (20)

t12192014@18
t12092014@37
t11252014@6
t11192014@25
t10212014@24
t10172014@18
t09252014@14
t07162015@28
t07152014@12
t07062015@13
t06042015@18
t05282015@27
t04242015@23
t03192015@35
t02242015@23
t02192015@15
t02062015@9
t01292015@27
11052014@20
04102015@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

See all →

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Same hazard · sterility