Red Mountain Compounding Recalls S-Hyaluronidase Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Hyaluronidase 150U/mL injection vials because the product lacks 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 an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Hyaluronidase 150U/mL Injection Solution (PF) in 5 mL vials. The recall is being conducted because the product lacks assurance of sterility.
The affected products are identified by Lot # S07232019DH@13 (Expiration 8/23/19) and Lot # S07312019DH@14 (Expiration 8/31/19). The quantity involved is 2x5 ml vials. The products were distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX
- Category
- Drug — Injectable Solution
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 #: S07232019DH@13
- Exp 8/23/19
- S07312019DH@14
- Exp 8/31/19
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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