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Class I: serious health riskTerminated

Results RNA Lubrisine eye drops Recall

Lubrisine eye drops (polyethylene glycol 400 0

Results RNA, LLC · Orem, UT

Risk level
Class I
Reported by FDA
Dec 26, 2018
Recall ID
D-0360-2019
Check your lot numberHow we source this data

Summary

Results RNA recalled Lubrisine eye drops starting Dec 14, 2018. The FDA classified it as Class I (serious health risk) and published enforcement report D-0360-2019 on Dec 26, 2018. Reason: Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver. Status: Terminated.

Why it was recalled

Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver

Product description

Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4

Lot numbers, UPCs & expiration codes

All Lots

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-0360-2019
Classification
Class I
Status
Terminated
Recall initiated
Dec 14, 2018
FDA report date
Dec 26, 2018
Quantity
10,297 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Results RNA, LLC

Original FDA data

Every field from FDA enforcement report D-0360-2019, exactly as published.

Show all FDA fields
City
Orem
State
UT
Status
Terminated
Country
United States
Event ID
81742
Address
1272 S 1380 W
Code information
All Lots
Postal code
84058-4911
Report date
Dec 26, 2018
Product type
Drugs
Recall number
D-0360-2019
Classification
Class I
Recalling firm
Results RNA, LLC
Product quantity
10,297 bottles
Termination date
Jan 29, 2021
Reason for recall
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
Distribution pattern
Nationwide within the United States
Recall initiation date
Dec 14, 2018
Initial firm notification
Telephone
Center classification date
Jan 14, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0360-2019, published Dec 26, 2018. 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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