Red Mountain Compounding Recalls S-MIC Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/mL B12 1mg/mL MDV Injection Solution vials because of 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 108 vials of S-MIC 25/50/50mg/mL B12 1mg/mL MDV Injection Solution. The product is available in 10 mL and 30 mL glass vials and was distributed nationwide in the United States. The recall is being conducted due to a lack of assurance of sterility.
The affected lots include S03272019DT@04, S01302019DT@08, S02192019DH@10, S03072019DH@01, S03042019DH@02, S04172019DT@03, S04302019DT@11, S05162019DH@20, S05292019DT@03, S06252019DH@17, S07172019DT@12, and S07182019DT@08. These lots have expiration dates ranging from August 19, 2019, to January 18, 2020.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.
- Category
- Drug — Injectable Solution
- 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 (20)
- Lot #: a) S03272019DT@04
- Exp 09/27/2019
- b) S01302019DT@08
- Exp 08/30/2019
- S02192019DH@10
- Exp 08/19/2019
- S03072019DH@01
- Exp 09/07/2019
- S03042019DH@02
- S03272019DT@04
- S04172019DT@03
- Exp 10/17/2019
- S04302019DT@11
- Exp 10/30/2019
- S05162019DH@20
- Exp 11/16/2019
- S05292019DT@03
- Exp 11/29/2019
- S06252019DH@17
- Exp 12/25/2019
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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