Red Mountain Compounding Recalls S-Folic Acid Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Folic Acid 10mg/ml injection vials 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are rated as Severe (4), as they carry a risk of hospitalization or significant injury, even if not explicitly reported in the text.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Folic Acid 10mg/ml MDV Injection. The product is packaged in 30ml glass vials and is available by prescription only. The recall involves specific lots with expiration dates in September 2019.
The recall was initiated because of a lack of assurance of sterility. This means the manufacturer cannot guarantee that the medication is free from microbial contamination. The affected products were distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled S-Folic Acid injections immediately. Patients who have received this medication should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, 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 (4)
- Lot #: S06162019DH@09
- Exp 9/16/19
- S06032019DT@01
- Exp 9/30/19
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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