Red Mountain Compounding Recalls S-Methylcobalamin Injections Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin 25mg/mL injections 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, and the hazard 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-Methylcobalamin 25mg/mL MDV Injection, 10ml glass vials. The recall is being conducted because the product lacks assurance of sterility.
The affected product is prescription-only and was distributed nationwide in the USA. The recall includes specific lots with expiration dates of August 8, 2019, and September 5, 2019.
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-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX
- Category
- Drug — Injectable
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 #:S05082019DT@16
- Exp 8/8/19
- S06052019DT@07
- Exp 9/5/19
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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