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Class II: temporary or reversible health riskTerminated

Assurance Infusion Autologous Serum 20% Eye Drops in 3 mL Recall

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

Assurance Infusion · Houston, TX

Risk level
Class II
Reported by FDA
Jan 22, 2020
Recall ID
D-0663-2020
Check your lot numberHow we source this data

Summary

Assurance Infusion recalled Autologous Serum 20% Eye Drops in 3 mL starting Dec 20, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0663-2020 on Jan 22, 2020. Reason: Lack of sterility assurance. Status: Terminated.

Why it was recalled

Lack of sterility assurance.

Product description

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0663-2020
Classification
Class II
Status
Terminated
Recall initiated
Dec 20, 2019
FDA report date
Jan 22, 2020
Quantity
32 droppers
Recall type
Voluntary: Firm initiated
Recalling firm
Assurance Infusion

Original FDA data

Every field from FDA enforcement report D-0663-2020, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
84546
Address
2626 S Loop W Ste 555
Code information
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
Postal code
77054-2652
Report date
Jan 22, 2020
Product type
Drugs
Recall number
D-0663-2020
Classification
Class II
Recalling firm
Assurance Infusion
Product quantity
32 droppers
Termination date
Oct 27, 2021
Reason for recall
Lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800
Distribution pattern
Nationwide within the United States
Recall initiation date
Dec 20, 2019
Initial firm notification
Letter
Center classification date
Jan 13, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0663-2020, published Jan 22, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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