Agency classClass IIOur severity:Severe FDA (Drugs)·D-0076-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls DMPS Injectable Solution Due to Sterility Concerns

JD & SN Inc. is recalling DMPS injectable solution because the FDA cannot ensure the product is sterile. Patients should stop using the medication and contact their healthcare provider.

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 recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable drug with a lack of assurance of sterility is categorized as Severe (Score 4) due to the potential for significant injury or adverse health consequences.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling DMPS (Dimercapto-Propanesulfonic Na) Injectable Solution, 500 mg/mL, 5mL syringes. The recall was initiated because the U.S. Food and Drug Administration (FDA) cannot ensure the sterility of the product. The affected product is a prescription-only injectable solution intended for single use.

The recall covers all sterile human compounded drugs within their expiration dates. The distribution pattern is listed as nationwide. The specific code information provided is t07012015@25.

Patients who have received this medication should stop using it and contact their healthcare provider for further instructions. The FDA has 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 recalled product

Product: DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY), Injectable Solution, 500 mg/mL, 5mL 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: 1

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 (1)

t07012015@25

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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