Agency classClass IIOur severity:Severe FDA (Drugs)·D-0145-2016·Announced 2015-11-04

FDA Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

JD & SN Inc. is recalling Testosterone/Anastrozole pellets because the FDA identified a lack of assurance of sterility for the compounded drugs.

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 recall as FDA Class II. According to the severity rubric, an FDA Class II recall is classified as Severe (Score 4), particularly when involving sterile compounded drugs where sterility assurance is compromised.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Testosterone/Anastrozole, Pellet, 120/8 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall was initiated due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.

The affected product consists of 20 pellets per unit. The specific lot codes involved are t05132014@15, t08262014@18, and t11112014@21. The distribution pattern for these products is listed as nationwide.

Patients who have received these specific compounded pellets should contact their healthcare provider or pharmacist for guidance on next steps. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 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: 20

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 (3)

t05132014@15
t08262014@18
t11112014@21.

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