Red Mountain Compounding Recalls Lidocaine Syringes Due to Sterility Concerns
Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% inhalation solution syringes due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in a medical product) fall under the Severe category, and the rule states that FDA Class I or II classifications generally warrant a score of 4 or higher when significant risks are present.
Plain-English summary
First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringes. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by Lot # S06242019DH@04 with an expiration date of 9/24/19. The recall is classified as FDA Class II. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx
- Category
- Drug — Compounded Medication
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 #: S06242019DH@04
- Exp 9/24/19
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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