The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0081-2016·Announced 2015-11-04

FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

Moses Lake Professional Pharmacy is recalling Estradiol 20 mg pellets because the FDA determined there is a lack of assurance of sterility.

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 recall for Estradiol, Pellet, 20 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall is being conducted because the agency has determined there is a lack of assurance of sterility for the product.

The affected product consists of 9 pellets per unit. The recall covers specific lots identified by the codes t12022014@19, t08132014@24, t08042014@40, t07082015@25, t06192015@25, t03192015@5, t02162015@11, and t02062015@12. The source text indicates that the distribution pattern for these products was nationwide.

Consumers who have these specific lots of Estradiol pellets should stop using them and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ESTRADIOL, Pellet, 20 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
Affected units
9

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)

  • t12022014@19
  • t08132014@24
  • t08042014@40
  • t07082015@25
  • t06192015@25
  • t03192015@5
  • t02162015@11
  • t02062015@12.

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 →

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