Agency classClass IIOur severity:Severe FDA (Drugs)·D-0080-2016·Announced 2015-11-04

FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns

JD & SN Inc. is recalling Estradiol 18 mg pellets because the company cannot assure the sterility of the product. The recall covers all sterile human compounded drugs within their expiry date.

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 states the agency classification is Class II. According to the rubric, an FDA Class II recall with potential for serious adverse health consequences (such as sterility failure in a compounded drug) corresponds to a severity score of 4 (Severe).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol, Pellet, 18 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is being conducted because the firm lacks assurance of the sterility of the product. The source text specifies that the recall applies to all sterile human compounded drugs within their expiry date.

The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The distribution pattern for the affected product is listed as nationwide.

Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to proceed. The source text does not provide specific lot numbers or dates beyond the general description of the product and the recall scope.

The recalled product

Product: ESTRADIOL, Pellet, 18 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: 1

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 (1)

t07312014@14

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 failure