Red Mountain Compounding Recalls Testosterone Propionate Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Propionate 100mg/mL in sesame oil because the product lacks 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL. The recall is being conducted because the product lacks assurance of sterility.
The affected product is a prescription-only medication packaged in 5ml glass vials. The recall covers two specific lot numbers: S04222019DH@03 with an expiration date of 10/22/2019, and S06162019DH@05 with an expiration date of 12/16/2019. The product was distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for these specific lot numbers. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or manufacturer for disposal or credit.
The recalled product
- Product
- S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, 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 (3)
- Lot #:S04222019DH@03 Exp 10/22/2019
- S06162019DH@05
- Exp 12/16/2019
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.
See all 100 products in this recall →Related recalls
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