Red Mountain Compounding Pharmacy Recalls S-Test Cyp/Prop/Deca-Nan Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Test Cyp/Prop/Deca-Nan 250mg/ml vials because the FDA determined there is 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable medication) are rated as Severe (4).
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Test Cyp/Prop/Deca-Nan 250mg/ml (80/10/10) in sesame oil. The product is a prescription-only medication packaged in 10ml glass vials. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by Lot # S06242019DH@06 and has an expiration date of 9/24/2019. The recall is classified as FDA Class II. The distribution pattern is listed as nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml 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 #: S06242019DH@06
- Exp 9/24/2019
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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