FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Cell Distributors Refresh Tears Recall

Refresh Tears (Carboxymethylcellulose Sodium Solution) 0

Cell Distributors · Union, NJ

Risk level
Class II
Reported by FDA
May 31, 2017
Recall ID
D-0865-2017
Check your lot numberHow we source this data

Summary

Cell Distributors recalled Refresh Tears starting Apr 3, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0865-2017 on May 31, 2017. Reason: Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel. Status: Terminated.

Why it was recalled

Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.

Product description

Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ

Lot numbers, UPCs & expiration codes

all lots Expiration date August 2019

Where it was sold

Nationwide

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-0865-2017
Classification
Class II
Status
Terminated
Recall initiated
Apr 3, 2017
FDA report date
May 31, 2017
Quantity
2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL)
Recall type
Voluntary: Firm initiated
Recalling firm
Cell Distributors

Original FDA data

Every field from FDA enforcement report D-0865-2017, exactly as published.

Show all FDA fields
City
Union
State
NJ
Status
Terminated
Country
United States
Event ID
76861
Address
675 Rahway Ave
Code information
all lots Expiration date August 2019
Postal code
07083-6683
Report date
May 31, 2017
Product type
Drugs
Recall number
D-0865-2017
Classification
Class II
Recalling firm
Cell Distributors
Product quantity
2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL)
Termination date
Jun 18, 2019
Reason for recall
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ
Distribution pattern
Nationwide
Recall initiation date
Apr 3, 2017
Initial firm notification
Letter
Center classification date
May 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0865-2017, published May 31, 2017. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls