Red Mountain Compounding Recalls S-Folic Acid Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Folic Acid 20mg/mL injection 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, particularly given the risk of infection associated with a lack of sterility assurance in an injectable medication.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Folic Acid 20mg/mL MDV Injection. The affected product is packaged in 10ml and 30ml glass vials and is available by prescription only. The recall is being conducted due to a lack of assurance of sterility.
The specific lots subject to this recall are S05162019DH@17 with an expiration date of 8/26/19, and S07262019DH@08 with an expiration date of 10/26/19. The product was distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the pharmacy or disposed of according to local regulations. Patients who have already received the medication should contact their healthcare provider for guidance.
The recalled product
- Product
- S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, 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 (4)
- Lot# S05162019DH@17
- Exp 8/26/19
- S07262019DH@08
- Exp 10/26/19
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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