Red Mountain Compounding Recalls S-Estradiol Cypionate Injections for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections due to 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable drug) corresponds to a severity score of 4 (Severe), as it implies a risk of adverse health consequences that are not merely theoretical or cosmetic.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Estradiol Cypionate 5mg/ml multi-dose vials. The affected products are packaged in 5ml and 10ml glass vials and are prescription-only. The recall involves a total of 11 vials across three specific lots: S05092019DH@08 (Exp 8/9/19), S06112019DH@14 (Exp 9/11/19), and S07222019DH@04 (Exp 10/22/19).
The recall was initiated due to a lack of assurance of sterility. The products were distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected vials immediately. Patients who have received these injections should contact their healthcare provider for further instructions. The recalling firm is responsible for managing the recall and ensuring the products are removed from distribution.
The recalled product
- Product
- S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
- Category
- Drug — Injectable Steroid
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 (6)
- Lot #: S05092019DH@08
- Exp 8/9/19
- S06112019DH@14
- Exp 9/11/19
- S07222019DH@04
- Exp 10/22/19
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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