Red Mountain Compounding Recalls S-Taurine Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Taurine 50mg/ml 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. The hazard involves a lack of assurance of sterility in a medical product, which carries a significant risk of infection or serious injury.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Taurine 50mg/ml MDV Soln, Rx only, 30ml glass vials. The recall is being conducted because the U.S. Food and Drug Administration (FDA) has determined there is a lack of assurance of sterility for the affected product.
The specific products subject to this recall are 3x30 ml glass vials with the following lot numbers and expiration dates: S07232019DH@12 (Exp 11/23/19) and S07292019DH@05 (Exp 11/29/19). These products were 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 removed from use and returned to the pharmacy or recalled firm in accordance with standard recall procedures.
The recalled product
- Product
- S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass 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 #: S07232019DH@12
- Exp 11/23/19
- S07292019DH@05
- Exp 11/29/19
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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