Agency classClass IIOur severity:Severe FDA (Drugs)·D-0066-2016·Announced 2015-11-04

FDA Recalls Compounded Chorionic Gonadotropin Syringes Due to Sterility Concerns

FDA is recalling 42 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the snippet, the lack of sterility in an injectable drug poses a significant risk, aligning with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 42 syringes of Chorionic Gonadotropin Compounded, Injectable Solution, 150 UNITS/0.150 ML per syringe. The product is manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The recall is classified as Class II by the FDA.

The reason for the recall is a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within expiry are affected by this issue. The distribution pattern for the recalled product 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 recall number is D-0066-2016.

The recalled product

Product: CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 150 UNITS/0.150 ML 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: 42

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)

t07012015@9

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