Red Mountain Compounding Pharmacy Recalls Lidocaine and Phenylephrine Injection Syringes
Red Mountain Compounding Pharmacy is recalling specific lots of lidocaine and phenylephrine injection syringes due to 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 agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in injectable products which carry significant risk of adverse health consequences.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling specific lots of S-LIDOCAINE HCL 1% / PHENYLEPHRINE 1.5% (PF) INJ SOLN, 1ml syringes. The recall was initiated because of a lack of assurance of sterility in the affected products.
The affected products are 3x1 ml syringes distributed nationwide in the USA. The specific lot numbers involved are S06192019DT@02 (Exp 8/19/19), S06262019DT@11 (Exp 8/26/19), and S07312019DH@06 (Exp 9/31/19).
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected syringes. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx
- Category
- Drug — Injectable Solution
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 (6)
- Lot #: S06192019DT@02
- Exp 8/19/19
- S06262019DT@11
- Exp 8/26/19
- S07312019DH@06
- Exp 9/31/19
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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