Red Mountain Compounding Recalls S-TEST CYP/NAN-DECA Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/NAN-DECA 200/50MG/ML MDV in sesame oil because the agency could not ensure the product was sterile.
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, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-TEST CYP/NAN-DECA 200/50MG/ML MDV in sesame oil. The product is a prescription-only medication packaged in 10ml glass vials. The recall was initiated due to a lack of assurance of sterility.
The affected product was distributed nationwide in the USA. The recall covers 3x10 ml glass vials from two specific lots: Lot # S07162019DH@08 (Expiration 10/16/19) and Lot # S05092019DH@05 (Expiration 8/9/19). The FDA has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx
- Category
- Drug — Compounded 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 (4)
- Lot #: S07162019DH@08
- Exp 10/16/19
- S05092019DH@05
- Exp 8/9/19
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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