Agency classClass IIOur severity:Severe FDA (Drugs)·D-0077-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls EDETATE CALCIUM DISODIUM Injectable Solution

JD & SN Inc. is recalling EDETATE CALCIUM DISODIUM 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 involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL syringe. The recall is being conducted because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry date.

The affected product is a prescription-only injectable solution. The recall covers the specific product identified in the notice, which was distributed nationwide. The source text does not specify the exact number of units recalled or the specific dates of distribution.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL 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@24

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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