Agency classClass IIOur severity:Severe FDA (Drugs)·D-0061-2016·Announced 2015-11-04

FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Concerns

The FDA is recalling 9 vials of Chorionic Gonadotropin Injectable Solution from Moses Lake Professional Pharmacy due to a 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from non-sterile injectable drugs.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Chorionic Gonadotropin, Injectable Solution, 4000 UNITS/mL, 8 mL vials. The product is recalled because there is a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.

The recall involves 9 vials manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The agency has classified this as a Class II recall. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions. The specific lot codes associated with this recall are t05062015@33, t08212014@16, and t02032015@14.

The recalled product

Product: CHORIONIC GONADOTROPIN, Injectable Solution, 4000 UNITS/ mL, 8 mL vial, 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 — Injectable Solution
Hazard: sterility
infection
Affected units: 9

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 (3)

t05062015@33
t08212014@16
t02032015@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

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