Red Mountain Compounding Recalls Testosterone Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Testosterone Half Ultra 125mg/mL 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, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the agency's Class II classification for a sterility issue in an injectable drug aligns with the Severe criteria.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Testosterone Half Ultra 125mg/mL MDV in Sesame Oil. The product is a prescription-only medication packaged in 5ml glass vials. The recall is being conducted because of a lack of assurance of sterility.
The affected product includes Lot # S05302019DT@03 with an expiration date of 08/30/2019. The recall covers products distributed nationwide in the USA. The FDA has classified this recall as Class II.
Consumers who have this specific product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
- Category
- Drug — Injectable Steroid
- 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 (1)
- Lot #: S05302019DT@03Exp 08/30/2019
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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