Agency classClass IIOur severity:Severe FDA (Drugs)·D-0087-2016·Announced 2015-11-04

FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns

The FDA is recalling Estradiol pellets from JD & SN Inc. because the manufacturer cannot ensure the sterile compounded drugs are free of contamination.

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 is assigned a score of 4 (Severe).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Estradiol, Pellet, 75 mg, 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 expiration dates.

The affected product consists of 6 pellets per unit. The recall covers lots with the following codes: t11122014@22, t10282014@8, t05122015@2, t02022015@17, and t01282014@25. The distribution pattern for these products is listed as nationwide.

Consumers and healthcare providers should stop using the affected Estradiol pellets and contact their healthcare provider or the recalling firm for further instructions. 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: ESTRADIOL, Pellet, 75 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-failure
Affected units: 6

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 (5)

t11122014@22
t10282014@8
t05122015@2
t02022015@17
t01282014@25.

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