Red Mountain Compounding Recalls Sterility-Compromised S-E2/Test Cyp Injection
Red Mountain Compounding Pharmacy is recalling S-E2/Test Cyp 1mg/4mg sesame oil injections 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-E2/Test Cyp 1mg/4mg sesame oil injections. The product is packaged in 10 ml glass vials and is available by prescription only.
The recall was initiated because of a lack of assurance of sterility. The affected lots are S05212019DT@06 (expiration date 5/21/19) and S06262019DT@08 (expiration date 6/26/19). The products were distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.
- Category
- Drug — 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 (4)
- Lot #: S05212019DT@06 Exp
- 5/21/19
- S06262019DT@08
- Exp 6/26/19
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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