Red Mountain Compounding Recalls S-Estradiol Cypionate Injections Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections because the FDA identified a lack of 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-Estradiol Cypionate 5mg/mL multi-dose vials. The product is packaged in 5ml, 10ml, and 11ml glass vials and is available by prescription only. The recall was initiated due to a lack of assurance of sterility.
The affected lots include S05092019DH@07, S05082019DT@11, S07032019DT@13, S07092019DT@09, and S07292019DH@03. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide in the USA. Patients who have received these specific lots should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.
- Category
- Drug — Injectable
- Hazard
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 (10)
- Lot #:S05092019DH@07
- Exp 8/9/19
- S05082019DT@11
- Exp 8/8/19
- S07032019DT@13
- Exp 10/3/19
- S07092019DT@09
- Exp 10/9/19
- S07292019DH@03
- Exp 10/29/19
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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