Agency classClass IIOur severity:Severe FDA (Drugs)·D-0070-2016·Announced 2015-11-04

FDA Recalls Compounded Chorionic Gonadotropin Injectable Solution Due to Sterility Concerns

FDA is recalling 64 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable drug with a lack of assurance of sterility falls under the 'Severe' category (Score 4), as it represents a significant risk of harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 64 syringes of CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML per syringe. The product is prescription-only and was manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington.

The recall was initiated due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry date. The affected product codes are t03272015@13 and t04292015@14. The distribution pattern is listed as nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall.

The recalled product

Product: CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 500 UNITS/0.5ML 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
infection
Affected units: 64

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)

t03272015@13 and t04292015@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

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Same hazard · sterility