Agency classClass IIOur severity:Severe FDA (Drugs)·D-0116-2016·Announced 2015-11-04

FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns

The FDA is recalling compounded progesterone pellets from JD & SN Inc. because the manufacturer cannot guarantee the products 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 rating under the rubric, particularly given the risk of serious injury from non-sterile compounded drugs.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling compounded progesterone pellets, 100 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall was initiated because the firm lacks assurance of the sterility of the products. The affected products are prescription-only and were distributed nationwide.

The recall covers 21-pellet packages with specific lot codes, including t12292014@29, t11262014@15, and t11202014@25, among others. The source text indicates that all sterile human compounded drugs within their expiry dates are affected by this lack of sterility assurance.

Consumers who have these specific progesterone pellets should contact their healthcare provider or the recalling firm for instructions on how to dispose of or return the product. The FDA advises patients to consult their healthcare professionals regarding alternative treatment options.

The recalled product

Product: PROGESTERONE, Pellet, 100 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: 21

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 (15)

t12292014@29
t11262014@15
t11202014@25
t11202014@10
t08292014@26
t07072015@20
t06222015@10
t06162015@16
t06012015@10
t05292014@20
t04302015@13
t04162015@8
t03102015@3
t02062015@13
t01062015@20.

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