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Class I: serious health riskOngoing

Kilitch Healthcare India Target brand High Performance Lubricant Eye Recall

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0

Kilitch Healthcare India Limited

Risk level
Class I
Reported by FDA
Feb 14, 2024
Recall ID
D-0300-2024
Check your lot numberHow we source this data

Summary

Kilitch Healthcare India recalled Target brand High Performance Lubricant Eye starting Nov 13, 2023. The FDA classified it as Class I (serious health risk) and published enforcement report D-0300-2024 on Feb 14, 2024. Reason: Non-Sterility. Status: Ongoing.

Why it was recalled

Non-Sterility

Product description

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403

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-0300-2024
Classification
Class I
Status
Ongoing
Recall initiated
Nov 13, 2023
FDA report date
Feb 14, 2024
Quantity
401,568 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Kilitch Healthcare India Limited

Original FDA data

Every field from FDA enforcement report D-0300-2024, exactly as published.

Show all FDA fields
City
Navi Mumbai
Status
Ongoing
Country
India
Event ID
93357
Address
R - 904 905 T T C Industrial Road
Code information
All lots
Report date
Feb 14, 2024
Product type
Drugs
Recall number
D-0300-2024
Classification
Class I
Recalling firm
Kilitch Healthcare India Limited
Product quantity
401,568 bottles
Reason for recall
Non-Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403
Distribution pattern
Nationwide within the United States
Recall initiation date
Nov 13, 2023
Initial firm notification
Press Release
Center classification date
Feb 5, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0300-2024, published Feb 14, 2024. 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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