Red Mountain Compounding Pharmacy Recalls S-Ascorbic Acid Vials for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling 81 vials of S-Ascorbic Acid 500mg/mL 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, an FDA Class II recall involving a significant hazard such as lack of sterility in a parenteral product corresponds to a Severe (4) rating.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 81 vials of S-Ascorbic Acid 500mg/mL MDV Soln (Non-Corn). The product is available in 50mL, 5mL, and 30mL glass vials and is prescription-only. The recall is being conducted due to a lack of assurance of sterility.
The affected lots were distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall documentation, including lots such as S04112019DT@07 and S07172019DT@09.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.
- Category
- Drug — Compounded Medication
- Hazard
- Affected units
- 81
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 (19)
- Lot #: a) S04112019DT@07
- Exp 8/11/19
- S05012019DT@01
- 9/1/19
- S05142019DT@13
- 9/14/19
- S05282019DT@07
- 9/28/19
- S06042019DT@05
- 10/4/19
- S06182019DH@15
- 10/18/19
- S07102019DT@13
- 12/10/19
- S07172019DT@09
- 12/17/19 b) S04172019DT@01
- 8/17/19
- c) S07172019DT@09
- 12/17/19
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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