Red Mountain Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Cypionate 100mg/mL in sesame oil 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 issue) 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-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only. The recall is limited to Lot # S05292019dt@01 with an expiration date of 8/29/19. The product consists of 1x5ml glass vials.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or report any specific illnesses or injuries associated with the product.
The affected product was distributed nationwide in the USA. Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, 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 #: S05292019dt@01
- Exp 8/29/19
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.
See all 100 products in this recall →Related recalls
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