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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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