Agency classClass IIOur severity:Severe FDA (Drugs)·D-0062-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Chorionic Gonadotropin Vials Due to Sterility Concerns

JD & SN Inc. is recalling 95 vials of Chorionic Gonadotropin because the FDA could not verify the sterility of the compounded drug.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile compounded drugs where sterility assurance is lacking.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 95 vials of Chorionic Gonadotropin, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial. The recall was initiated because the FDA could not verify the assurance of sterility for these sterile human compounded drugs.

The affected products are prescription-only and were distributed nationwide. The recall covers specific lots with codes t12172014@5, t12162014@23, t09102014@8, t05272015@14, t05222015@20, t03202015@23, t03062015@32, and t02122015@14. The source text notes that all sterile human compounded drugs within expiry are subject to this lack of assurance.

Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 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 — Compounded Injectable
Hazard: sterility-failure
Affected units: 95

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 (8)

t12172014@5
t12162014@23
t09102014@8
t05272015@14
t05222015@20
t03202015@23
t03062015@32
and t02122015@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 failure