Red Mountain Compounding Recalls S-Procaine HCL 1% Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling S-Procaine HCL 1% Buffered MDV 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 source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential contamination or sterility issues in injectable medications.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Procaine HCL 1% Buffered MDV, a prescription-only medication packaged in 30ml glass vials. The recall is being conducted due to a lack of assurance of sterility in the product.
The affected product is identified by Lot # S0726209DH@07 and has an expiration date of 10/26/19. The recall is classified as FDA Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The product was distributed nationwide in the USA. Consumers and healthcare providers who have this specific lot of S-Procaine HCL 1% Buffered MDV should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.
- Category
- Drug — Injectable 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 (2)
- Lot #: S0726209DH@07
- Exp 10/26/19
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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