Agency classClass IIOur severity:Severe FDA (Drugs)·D-0063-2016·Announced 2015-11-04

FDA Recalls Chorionic Gonadotropin Syringes Due to Sterility Concerns

The FDA is recalling 834 syringes of Chorionic Gonadotropin compounded by Moses Lake Professional Pharmacy because the agency cannot ensure the product is 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 834 syringes of Chorionic Gonadotropin, Injectable Solution, 175 UNITS/1.5mg per syringe with Methylcobalamin. The product is compounded 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 their expiry dates are affected by this issue. The specific lot codes associated with the recalled units are listed in the product metadata.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall is distributed nationwide.

The recalled product

Product: CHORIONIC GONADOTROPIN, Injectable Solution,175 UNITS/1.5mg per syringe with Methylcobalamin, 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: 834

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 (18)

04292015@12
05042015@8
05202015@21
06102015@25
06242015@14
07012015@8
07062015@21
t03062015@15
t03122015@33
t03182015@45
t03192015@2
t04082015@14
t04082015@3
t04202015@22
t05082015@27
t05192015@29
t06022015@37
and t07152015@5.

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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