Agency classClass IIOur severity:Severe FDA (Drugs)·D-0060-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Compounded Vitamin Injectable Solution

JD & SN Inc. is recalling compounded vitamin injectable solutions 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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile compounded drugs where sterility assurance is compromised.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling specific lots of CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution. The product is a 30 mL vial, prescription-only compounded drug. The recall involves 4 vials per lot for the identified lot codes.

The recall was initiated because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The FDA has classified this recall as Class II. The products were distributed nationwide.

Patients who have received these specific compounded injectable solutions should contact their healthcare provider or the pharmacy for further instructions. Consumers should not use the recalled products.

The recalled product

Product: CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 30 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: lack-of-sterility
Affected units: 4

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)

t06112015@21
t06172015@43
t07062015@30

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 · lack of sterility