Agency classClass IIOur severity:Severe FDA (Drugs)·D-0217-2020·Announced 2019-11-13

Red Mountain Compounding Recalls S-Edetate Calcium Injection Due to Sterility Concerns

Red Mountain Compounding Pharmacy is recalling S-Edetate Calcium 300mg/mL injection vials because the FDA identified 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 identifies the hazard as a 'Lack of Assurance of Sterility' for an injectable medication. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects in medical products are classified as Severe (Score 4).

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Edetate Calcium 300mg/mL Injection Solution. The product is packaged in 50ml and 100ml glass vials and is available by prescription only. The recall involves specific lots distributed nationwide in the USA.

The recall was initiated due to a lack of assurance of sterility. This means the FDA cannot guarantee that the medication is free from microbial contamination. The affected lots include S04232019DT@07, S07302019DH@09, S05142019DT@14, S06182019DH@30, and S06182019DH@13.

Patients who have received this medication should contact their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Manufacturer: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility
contamination

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 (9)

Lot #: a) S04232019DT@07
Exp 8/23/19
S07302019DH@09
Exp 11/30/19
b) S05142019DT@14
Exp 9/14/19
S06182019DH@30
Exp 10/18/19
S06182019DH@13

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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