Red Mountain Compounding Recalls S-Nandrolone Decanoate Injections for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Nandrolone Decanoate injections due to a lack of assurance of sterility. The affected lot is distributed nationwide.
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 involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterility issue in an injectable drug aligns with the Severe criteria for significant risk.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Nandrolone Decanoate 200mg/mL multi-dose vials in sesame oil. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is identified by Lot # S07022019DT@02 with an expiration date of 10/2/19. The product is a prescription-only medication packaged in 10ml glass vials. The recall covers distribution nationwide in the USA.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
- Category
- Drug — Injectable Steroids
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 #: S07022019DT@02
- Exp 10/2/19
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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