Red Mountain Compounding Recalls S-TEST CYP 50MG/ML MDV Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-TEST CYP 50MG/ML MDV vials 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in injectable products.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vials. The recall is being conducted because the product lacks assurance of sterility.
The affected product is identified by Lot # S06162019DH@02 with an expiration date of 9/16/19. The recall covers products distributed nationwide in the USA.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx
- Category
- Drug — Compounded 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 (2)
- Lot #: S06162019DH@02
- Exp 9/16/19
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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