Red Mountain Compounding Pharmacy Recalls Sterility-Compromised CYP/PROP Vials
Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in Ethyl Oleate 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 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 drug recalls involving potential health risks such as sterility issues.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in Ethyl Oleate. The product is a prescription-only medication available in 10ml and 13ml glass vials. The recall was initiated because of a lack of assurance of sterility.
The affected products are distributed nationwide in the USA. The specific lot numbers involved are S05212019DH@13 (Exp 8/21/19), S06302019DH@07 (Exp 9/30/19), S07252019DH@10 (Exp 10/25/19), and S05092019DH@05 (Exp 8/9/19). The source text does not specify the exact number of units recalled or the specific states or facilities where the product was distributed.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the pharmacy or manufacturer. Patients who have already used the product should consult their healthcare provider regarding any potential risks associated with the lack of sterility assurance.
The recalled product
- Product
- S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
- 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 (8)
- Lot #: a) S05212019DH@13
- Exp 8/21/19
- S06302019DH@07
- Exp 9/30/19
- S07252019DH@10
- Exp 10/25/19
- b) S05092019DH@05
- Exp 8/9/19
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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