Agency classClass IIOur severity:Severe FDA (Drugs)·D-0059-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Injectable Vitamin and Amino Acid Solution

Moses Lake Professional Pharmacy is recalling 22 vials of a compounded 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterile injectable product aligns with the Severe criteria for significant risk.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 22 vials of B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution. The product is a prescription-only compounded drug available in 30 mL vials.

The recall was initiated because of a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within their expiry date are affected by this issue. The recall is classified as FDA Class II.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled vials and contact the pharmacy or their healthcare provider for further instructions.

The recalled product

Product: B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/5/1/10/25/8/17/17 MG/ML, 30 mM 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
infection
Affected units: 22

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 (4)

t05212015@13
t06032015@22
t06102015@17
t06292015@19

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