Agency classClass IIOur severity:Severe FDA (Drugs)·D-0069-2016·Announced 2015-11-04

FDA Recalls Compounded Chorionic Gonadotropin Syringes Due to Sterility Concerns

FDA is recalling 40 syringes of compounded chorionic gonadotropin from Moses Lake Professional Pharmacy due to 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While the source does not explicitly mention hospitalizations, the lack of sterility in an injectable drug presents a significant risk of serious adverse health consequences, aligning with the Severe criteria for significant injury reports or high-risk contamination.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 40 syringes of Chorionic Gonadotropin Compounded, Injectable Solution, 250 UNITS/0.25ML per syringe. The product was compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The recall was initiated because of a lack of assurance of sterility for the sterile human compounded drugs within their expiry date.

The recalled product is a prescription-only injectable solution. The specific code associated with the recall is t04292015@13. The distribution pattern for these syringes is listed as nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling pharmacy 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: CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 250 UNITS/0.25ML per syringe, 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 Injectable
Hazard: sterility
injection
Affected units: 40

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)

t04292015@13

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 →

Severe
FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Six Trimix Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2015-11-04

Same hazard · sterility