Assurance Infusion Recalls Autologous Serum Eye Drops Due to Sterility Concerns
Assurance Infusion is recalling specific lots of Autologous Serum 20% Eye Drops 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 rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in an ophthalmic product presents a significant risk of harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
Assurance Infusion is voluntarily recalling 32 droppers of Autologous Serum 20% Eye Drops in 3 mL droppers. The recall is being conducted due to a lack of sterility assurance in the product.
The affected lots are 12092019@33 (Exp. 03/08/2020), 11112019@30 (Exp. 02/09/2020), 10012019@17 (Exp. 12/30/2019), 10162019@18 (Exp. 01/14/2020), and 10252019@11 (Exp. 01/23/2020). The product was distributed nationwide within the United States.
Consumers should stop using the recalled eye drops and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 32
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 (5)
- Lots: 12092019@33 Exp. 03/08/2020
- 11112019@30 Exp. 02/09/2020
- 10012019@17 Exp. 12/30/2019
- 10162019@18 Exp. 01/14/2020
- 10252019@11 Exp. 01/23/2020
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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