Assurance Infusion Recalls Phenol 2.5% Sterile Solution Due to Sterility Concerns
Assurance Infusion is recalling two syringes of Phenol 2.5% Sterile Solution because of a lack of sterility assurance.
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, and the hazard involves a lack of sterility assurance in a sterile medical solution, which poses a significant risk of infection or serious injury.
Plain-English summary
Assurance Infusion is voluntarily recalling two syringes of Phenol 2.5% Sterile Solution in 50 mL syringes. The recall is being conducted due to a lack of sterility assurance for the product.
The affected product was distributed nationwide within the United States. The specific lots involved are 10142019@14 with an expiration date of 01/12/2020, and 11042019@8 with an expiration date of 02/02/2020.
Consumers and healthcare providers should stop using the recalled product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Sterile Solution
- Hazard
- Affected units
- 2
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: 10142019@14 Exp. 01/12/2020
- 11042019@8 Exp. 02/02/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion 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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