Agency classClass IIOur severity:Severe FDA (Drugs)·D-0146-2016·Announced 2015-11-04

FDA Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

FDA is recalling Testosterone/Anastrozole pellets from Moses Lake Professional Pharmacy because the agency cannot ensure the sterile compounded drugs are sterile.

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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Testosterone/Anastrozole, Pellet, 200/13 mg, Rx only, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.

The affected product consists of 60 pellets. The recall covers lots with the following codes: t09262014@23, t07282014@9, t07012014@11, t06092015@8, t05132015@6, t02172015@13, t01232015@7, and 07222015@1. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 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: 60

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)

t09262014@23
t07282014@9
t07012014@11
t06092015@8
t05132015@6
t02172015@13
t01232015@7
07222015@1.

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