Red Mountain Compounding Recalls Lidocaine Vials Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCl 1% vials because the FDA identified 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications with potential for serious harm.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling 13 vials of S-LIDOCAINE HCL 1% MDV SOLN, 50ML. The recall was initiated due to a lack of assurance of sterility in the product.
The affected product was distributed nationwide in the USA. The specific lots involved are S06112019DH@16 (Exp 9/11/19), S06182019DT@02 (Exp 9/18/19), S06182019DH@33 (Exp 9/18/19), S06252019DT@08 (Exp 9/25/19), and S08022019DH@01 (Exp 11/2/19).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx
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 (9)
- Lot #: S06112019DH@16
- Exp 9/11/19
- S06182019DT@02
- Exp 9/18/19
- S06182019DH@33
- S06252019DT@08
- Exp 9/25/19
- S08022019DH@01
- Exp 11/2/19
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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