Agency classClass IIOur severity:Severe FDA (Drugs)·D-0065-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Chorionic Gonadotropin Due to Sterility Concerns

JD & SN Inc. is recalling specific vials of Chorionic Gonadotropin injectable solution because the agency could not ensure the sterile human compounded drugs were 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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a sterile injectable drug where sterility assurance is lacking is classified as Severe (Score 4) due to the potential for significant injury or adverse health consequences.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling specific vials of Chorionic Gonadotropin, Injectable Solution, 5000 UNITS/0.1 mL. The recall involves vials in 5 mL, 6 mL, 8 mL, and 10 mL sizes. The total quantity recalled is 9 (5mL) vials, 2 (6mL) vials, 8 (8mL) vials, and 2 (10mL) vials.

The recall was initiated due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The FDA classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot codes listed in the recall notice and stop using the affected vials. Those who have questions regarding the recall should contact the recalling firm at (509) 764-2314.

The recalled product

Product: CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, 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

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)

t12292014@35
t12192014@15
t12162014@29
t10232014@24
t09162014@29
t09032014@6
t07252014@16
t07142015@6
t07022015@8
t06152015@32
t05272015@33
t04282015@11
t04162015@34
t04092015@8
t04022015@30
t02262015@24
t02032015@21
and t01232015@10

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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