Red Mountain Compounding Recalls S-Pyridoxine HCL Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Pyridoxine HCL (B6) vials 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 involves a lack of assurance of sterility, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 38 vials of S-Pyridoxine HCL (B6) 100mg/mL. The product is a prescription-only medication packaged in 30ml glass vials.
The recall was initiated due to a lack of assurance of sterility. The affected lots were distributed nationwide in the United States.
Consumers with this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
- Category
- Drug — Compounded Prescription
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 (16)
- Lot #: S03072019DH@10
- Exp 9/7/19
- S04162019DT@18
- Exp 10/16/19
- S05162019DH@09
- Exp 11/16/19
- S05232019DT@11
- Exp 11/23/19
- s06182019dh@31
- Exp 12/18/19
- S06242019DH@14
- Exp 12/24/19
- S07172019DT@08
- Exp 1/17/20
- S07232019DH@16
- Exp 1/23/20
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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