Red Mountain Compounding Recalls S-Hydroxocobalamin Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Hydroxocobalamin 1000mcg/mL injection 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 the hazard involves a lack of assurance of sterility in an injectable medication, 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-Hydroxocobalamin 1000mcg/mL MDV Injection. The product is packaged in 10mL and 30mL glass vials. The recall is being conducted because of a lack of assurance of sterility.
The affected product is identified by Lot # S07162019DT@04 with an expiration date of 10/16/19. The recall covers distribution 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-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx
- Category
- Drug — Injectable 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 (3)
- Lot #:a) S07162019DT@04
- Exp 10/16/19
- b) S07162019DT@04 Exp 10/16/19
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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