Red Mountain Compounding Recalls S-Manganese Chloride Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Manganese Chloride vials because the FDA determined there is a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 rating 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-Manganese Chloride 0.1mg/mL MDV Soln, 10 mL vials. The recall is being conducted due to a lack of assurance of sterility in the product.
The affected product consists of 2x10 ml vials with lot numbers S05082019DT@01 (expiration date 9/8/19) and S05222019DH@03 (expiration date 9/22/19). The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx
- Category
- Drug — Compounded 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 #: S05082019DT@01
- Exp 9/8/19
- S05222019DH@03
- Exp 9/22/19
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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