Red Mountain Compounding Recalls S-Procaine HCL 2% Buffered Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Procaine HCL 2% Buffered due to a lack of assurance of sterility. The affected prescription products were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a lack of assurance of sterility, which poses a risk of harm (infection) but the source does not report specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Procaine HCL 2% Buffered, a prescription-only medication. The recall is being conducted because of a lack of assurance of sterility in the product. The affected items include single-dose 10ml prefilled vials and 30ml glass multi-dose vials.
The recall covers specific lots of the product that were distributed nationwide in the United States. The source text does not specify the exact number of units affected or the specific dates of distribution beyond the lot expiration dates provided in the product information.
Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx
- Category
- Drug — Compounded Prescription
- 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) S04162019DH@04
- Exp 8/16/19
- S04182019DT@11
- Exp 8/18/19
- S04302019DT@08
- Exp 8/30/19
- S05292019DT@11
- Exp 9/29/19
- S06092019DH@08
- Exp 10/9/19
- S06252019DH@15
- Exp 10/25/19
- S07022019DH@10
- Exp 11/2/19
- S07292019DH@11
- Exp 11/29/19
- b) S06032019DT@02
- Exp 10/3/19
- S07232019DH@03
- Exp 11/23/19
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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