Medications & Supplements/Topical Products

Allergan, PLC.: Refresh Relieva Lubricant Eye Drops Recalled for Missing Instructions

Agency Publication Date: January 19, 2021

Summary

Approximately 100,634 bottles of Refresh Relieva PF Preservative-Free Lubricant Eye Drops (0.33 fl oz / 10 mL) are being recalled because they are missing the required instructions for use insert. These sterile eye drops were distributed nationwide to pharmacies and retailers between December 2020 and January 2021. Consumers may not have the necessary guidance for the safe and effective administration of this product due to the missing documentation.

Risk

The absence of the instructions for use insert can lead to incorrect administration of the eye drops or a failure to follow safety precautions. While no injuries have been reported, proper instructions are essential for maintaining the sterility and effectiveness of the medication during use.

What You Should Do

Check your Refresh Relieva PF Preservative-Free Lubricant Eye Drops (0.33 fl oz / 10 mL) for UPC 3 00236 63410 0 and NDC 0023-6634-10 printed on the label or box.
Identify if your bottle is from the affected batches by looking for Lot T0392 with an expiration date of July 2022, or Lot T0843 with an expiration date of August 2022.
If you have an affected bottle that is missing the instructions for use insert, contact your healthcare provider or pharmacist for guidance on proper use or concerns regarding the product.
Return any unused product from these specific lots to the place of purchase for a refund.
Contact Allergan, PLC. (an AbbVie company) for further instructions regarding this recall or to request the missing product information.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug product return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Refresh Relieva PF Preservative-Free Lubricant Eye Drops (0.33 fl oz / 10 mL)

Model:

NDC 0023-6634-10

UPC Codes:

300236634100

Lot Numbers:

T0392 (Exp. Jul. 2022)

T0843 (Exp. Aug. 2022)

Date Ranges: Expiration July 2022, Expiration August 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87016

Status: Resolved

Manufacturer: Allergan, PLC.

Sold By: Pharmacies; Retailers

Manufactured In: United States

Units Affected: 100,634 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your Refresh Relieva PF Preservative-Free Lubricant Eye Drops (0.33 fl oz / 10 mL) for UPC 3 00236 63410 0 and NDC 0023-6634-10 printed on the label or box.

Identify if your bottle is from the affected batches by looking for Lot T0392 with an expiration date of July 2022, or Lot T0843 with an expiration date of August 2022.

If you have an affected bottle that is missing the instructions for use insert, contact your healthcare provider or pharmacist for guidance on proper use or concerns regarding the product.

Return any unused product from these specific lots to the place of purchase for a refund.

Contact Allergan, PLC. (an AbbVie company) for further instructions regarding this recall or to request the missing product information.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.