Red Mountain Compounding Recalls S-HCG 3000 U/ML Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-HCG 3000 U/ML vials because the FDA determined there is 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product is prescription-only and was distributed nationwide in the USA. The recall covers 8x10 ML vials from specific lots: S06272019DT@07 (Exp 8/27/19), S07262019DH@04 (Exp 9/26/19), and S07302019DH@04 (Exp 9/30/19).
Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, they should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
- Category
- Drug — Compounded Medication
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 (6)
- Lot #: S06272019DT@07
- Exp 8/27/19
- S07262019DH@04
- Exp 9/26/19
- S07302019DH@04
- Exp 9/30/19
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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