Red Mountain Compounding Pharmacy Recalls Lidocaine HCL Injection Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% Injection because the product lacks 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant potential harm, specifically the lack of assurance of sterility in an injectable medication.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Lidocaine HCL 2% MDV Injection Solution packaged in 50ml vials. The recall is being conducted because the product lacks assurance of sterility.
The affected product includes 6 vials from two specific lots: S07092019DT@20 with an expiration date of 10/9/19, and S07242019DH@08 with an expiration date of 10/24/19. These products were distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the pharmacy or the recalling firm for further instructions.
The recalled product
- Product
- S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,
- Category
- Drug — Injectable
- Hazard
- Affected units
- 6
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 (4)
- Lot #:S07092019DT@20
- Exp 10/9/19
- S07242019DH@08
- Exp 10/24/19
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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