Red Mountain Compounding Recalls S-Edetate Disodium Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Edetate Disodium 15% Injection because the product lacks 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in injectable products which carry significant risk.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Edetate Disodium 15% Injection packaged in 50ml glass vials. The recall is being conducted because the product lacks assurance of sterility.
The affected product is prescription-only and was distributed nationwide in the USA. The recall covers 10 50 ml vials from specific lots with expiration dates in August 2019. The lot numbers are S07232019DH@14, S07162019DT@06, and S07172019DT@04.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. The FDA has classified 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 DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.
- Category
- Drug — Injectable
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 (3)
- Lot #:S07232019DH@14 Exp 8/23/19
- S07162019DT@06 Exp 8/16/19
- S07172019DT@04 Exp 8/17/19
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 →Related recalls
Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
See all →- SevereMIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTestosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereRed Mountain Compounding Test Cypionate Sterility Assurance Recall
FDA (Drugs) · 2021-11-03
- SevereTEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- HighTEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
FDA (Drugs) · 2021-11-03
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereRXQ Compounding Recalls EDETATE DISODIUM 15% INJECTABLE Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- ModerateSodium Selenite Injectable Solution Recalled for Sterility Concerns
FDA (Drugs) · 2021-11-03
- SevereRXQ Compounding Recalls EDETATE CALCIUM DISODIUM INJECTABLE Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereRXQ Compounding Recalls EDETATE DISODIUM 30% INJECTABLE Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereMIT/B12 Compounded Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereEstradiol Valerate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03