Agency classClass IIOur severity:Severe FDA (Drugs)·D-0118-2016·Announced 2015-11-04

FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns

The FDA is recalling compounded progesterone pellets from Moses Lake Professional Pharmacy because the agency cannot ensure 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 source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a risk of harm (lack of sterility) without reported fatalities or specific hospitalization reports falls under the 'Severe' category (Score 4), as it is not a Class I recall but involves a significant safety defect.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling compounded progesterone pellets, 50mg, 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 is a prescription-only medication consisting of 5 pellets. The recall covers lots with the following codes: t10292014@22, t09022014@13, t08262014@11, t06192015@24, and t05072014@11. The products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled progesterone pellets and contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: PROGESTERONE, Pellet, 50mg, 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: lack-of-sterility
infection-risk
Affected units: 5

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)

t10292014@22
t09022014@13
t08262014@11
t06192015@24
t05072014@11.

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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FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2015-11-04

Same hazard · lack of sterility