Red Mountain Compounding Recalls S-TEST CYP Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-TEST CYP 25mg/ml vials nationwide due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, particularly given the risk of infection associated with non-sterile injectable medications.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, a prescription-only medication. The product is available in 5 ml, 10 ml, and 13 ml glass vials. The recall covers 91 vials distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. The affected lots have expiration dates ranging from August 19, 2019, to January 26, 2020. Specific lot numbers include S02192019DH@14, S02282019DH@06, and S03142019DT@04, among others.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml 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 (20)
- Lot #: S02192019DH@14
- Exp 8/19/19
- S02282019DH@06
- Exp 8/28/19
- S03142019DT@04
- Exp 9/14/19
- S03252019DH@03
- Exp 9/25/19
- S04102019DT@05
- Exp 10/10/19
- S05012019DT@03
- Exp 11/1/19
- S05022019DT@11
- Exp 11/2/19
- s05012019dt@09
- S5212019DH@14
- Exp 11/21/19
- S06032019DT@07
- Exp 12/3/19
- S06122019DT@08
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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