Agency classClass IIOur severity:Severe FDA (Drugs)·D-0249-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls S-SOD Citrate Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-SOD Citrate 4% Injection due to a lack of assurance of sterility. The affected product was distributed nationwide.

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, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-SOD Citrate 4% Injection Solution, 10 mL glass vials. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product is identified by Lot Number S07102019DT@12 and has an expiration date of August 10, 2019. The recall involves 3x10 mL glass vials. The product was distributed nationwide in the United States.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product: S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Compounded Injectable
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 (2)

Lot #: S07102019DT@12
Exp 8/10/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding 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 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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