Red Mountain Compounding Recalls S-Hydroxocobalamin Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Hydroxocobalamin 5000mcg/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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Hydroxocobalamin 5000mcg/mL injection, 30mL glass vials. The recall is due to a lack of assurance of sterility in the product.
The affected product is identified by Lot Number S05232019DT@01 and has an expiration date of 8/23/19. The recall covers products 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-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx
- Category
- Drug — Injectable Medication
- 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 (2)
- Lot#: S05232019DT@01
- Exp 8/23/19
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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