Nationwide Recall, Multiple Brands of Eye Ointment - MedWaste Management Nationwide Recall, Multiple Brands of Eye Ointment - MedWaste Management

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FDA Recall, Eye Ointment, CVS Health, Equate, AACE

Nationwide Recall, Multiple Brands of Eye Ointment

In cooperation with the FDA, Brassica Pharma Pvt. Ltd. In Thane, Maharashtra, India has issued a voluntary recall of several brands of eye ointment due to a possible breach in sterility. The FDA discovered the breach during a routine inspection of the manufacturing facility. The products are distributed throughout the USA via retailers such as Walmart and CVS and are branded as Equate, CVS Health, and AACE Pharmaceuticals.

As of the writing of this notice, the FDA has not reported any adverse events as a result of the lack of sterility.

SUMMARY

 

Date of Recall:

Announced: February 22, 2024

Public Notification: February 26, 2024

 

Name(s) of Drug:

Multiple brands and ointments named

See chart below

 

Company Name:

Brassica Pharma Pvt. Ltd.

 

Drug Indication:

Dry Eyes

Eye Irritation

 

Equate Eye Lubricant Ointment FDA recall packaging
Equate Stye Lubricant Ointment FDA recall packaging
CVS Health Lubricant Eye Ointment Packaging FDA Recall
AACE Eye Lubricant Packaging FDA Recall

Images courtesy of FDA.gov 

 

Product Description

The eye ointment is packaged in tubes containing 0.12 oz or 1/8 oz quantities. Each tube is shipped/sold in a cardboard box bearing the coordinating brand’s logo and name. They were distributed to the general public nationwide through retailers such as Walmart and CVS, as well as AACE Pharmaceuticals.  

Reason for Recall

The FDA, during a routine inspection of the manufacturing facility, noted that practices within the process were resulting in a lack of sterility of the products.

Impacts

Consumers who use the contaminated eye ointment are at risk of developing eye infections. These infections can lead to pain or loss of sight and may spread throughout the body, leading to death.

Lot Information

Consumers who use any of these brands of eye ointment are strongly encouraged to check the listing below against the information on their eye drop packaging. If the information matches, read further to determine what actions must be taken to participate in the recall.

 

Product Name

Package Description

Brand Name

NDC #

Lot #

Exp. Date

 

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols)

3.5 gram tube, packaged in cardboard box with UPC Code 681131395298

Equate

79903-026-35

A2E01

Apr-24

 

A2L05

Nov-24

 

A3B01

Jan-25

 

A3C01

Feb-25

 

A3H05

Jul-25

Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil)

3.5 gram tube, packaged in cardboard box with UPC Code 681131395304

Equate

79903-
028-35

A2D08

Mar-24

A2F02

May-24

A2I03

Aug-24

A2L03

Nov-24

A2L04

Nov-24

A3C03

Feb-25

A3C05

Feb-25

A3H01

Jul-25

A3H03

Jul-25

 

CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil

3.5 gram tube, packaged in cardboard box with UPC Code 050428634141

CVS Health

76168-
707-35

A2F03

May-24

 

A2I02

Aug-24

 

A2L02

Nov-24

 

A3C04

Feb-25

 

A3H04

Jul-25

 

Lubricant PM Ointment

3.5 gram tube, packaged in cardboard box with UPC Code 371406124356

AACE Pharmaceuticals

71406-
124-35

A2G01

Jun-24

 

A2G02

Jun-24

 

A3F08

May-25

 

A3F09

May-25

 

A3J17

Sep-25

 

A3J18

Sep-25

             

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

 

Consumers

  1. Call your doctor right away. Report the use of the recalled medication.
  2. Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  3. Consumers with questions may contact Brassica Pharma Pvt. Ltd. by phone at 1-833-225-9564. You can also contact them via email at info@brassicapharma.com.
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Brassica Pharma Pvt. Ltd. by phone at 1-833-225-9564 or utilize info@brassicapharma.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Brassica Pharma Pvt. Ltd. by phone at 1-833-225-9564 or utilize info@brassicapharma.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!


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