Red Mountain Compounding Pharmacy Recalls S-TEST CYP Vials for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-TEST CYP 200mg/ml vials nationwide due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, a prescription-only medication. The product is available in 5ml, 10ml, and 13ml glass vials. The recall covers 559 vials distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these products.
Consumers who have purchased or received these vials should stop using them and contact their healthcare provider or the pharmacy for further instructions. The recall includes multiple lot numbers with expiration dates ranging from August 2019 to January 2020.
The recalled product
- Product
- S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
- Category
- Drug — Compounded Prescription
- 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 (13)
- Lot #: S02072019DT@08
- EXP 9/7/19
- S02132019DH@06
- Exp 8/13/19
- S02232019DH@06 Exp 8/23/19
- S02282019DH@07 Exp 8/28/19
- S02252019DH@01 Exp 8/25/19
- S02122019DH@06 Exp 8/12/19
- S03132019DT@02 Exp 9/13/19
- 03202019DT@01 Exp 9/20/19
- S06252019DH@15
- 9/30/19 S06182019DH@23 Exp
- 11/30/19
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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