Agency classClass IIOur severity:Severe FDA (Drugs)·D-0071-2016·Announced 2015-11-04

FDA Recalls Chorionic Gonadotropin/Cyanocobalamin Injectable Syringes Due to Sterility Concerns

JD & SN Inc. is recalling 42 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution 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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 42 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution, 1000 units/1 mL per syringe. The product is a prescription-only injectable solution manufactured by the pharmacy.

The recall was initiated because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The affected products were distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 1000 units/1 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 — Injectable Solution
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 (3)

t05112015@18
t05222015@21
t06092015@1

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