Brassica Pharma Pvt. Eye ointment products recall: Due to Potential Lack of Sterility Assurance
Due to Potential Lack of Sterility Assurance.
The hazard: Sterility or particulate concern
Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
What the notice says: Due to Potential Lack of Sterility Assurance.
Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.
Symptoms and when to call a doctor
Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Published
- February 22, 2024
- Risk level
- Elevated risk
- Issued by
- U.S. Food and Drug Administration
- Brand
- Brassica Pharma Pvt.
- Product type
- Prescription & OTC drugs
- Distribution
- Nationwide
- Sold at
- Walmart, CVS
- UPC codes
- 681131395298, 681131395304, 050428634141, 371406124356
Products covered by this recall
Eye ointment products
What the company announced
FOR IMMEDIATE RELEASE – 12 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA).
Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.
- Product Name: Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols) · Package Description: 3.5 gram tube, packaged in cardboard box with UPC Code 681131395298 · Brand Name: Equate · NDC: 79903-026-35 · Lot# Exp Date: A2E01 · Exp Date: Apr-24
- Product Name: A2L05 · Package Description: Nov-24
- Product Name: A3B01 · Package Description: Jan-25
- Product Name: A3C01 · Package Description: Feb-25
- Product Name: A3H05 · Package Description: Jul-25
- Product Name: Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil) · Package Description: 3.5 gram tube, packaged in cardboard box with UPC Code 681131395304 · Brand Name: Equate · NDC: 79903- 028-35 · Lot# Exp Date: A2D08 · Exp Date: Mar-24
- Product Name: A2F02 · Package Description: May-24
- Product Name: A2I03 · Package Description: Aug-24
- Product Name: A2L03 · Package Description: Nov-24
- Product Name: A2L04 · Package Description: Nov-24
- Product Name: A3C03 · Package Description: Feb-25
- Product Name: A3C05 · Package Description: Feb-25
- Product Name: A3H01 · Package Description: Jul-25
- Product Name: A3H03 · Package Description: Jul-25
- Product Name: CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil · Package Description: 3.5 gram tube, packaged in cardboard box with UPC Code 050428634141 · Brand Name: CVS Health · NDC: 76168- 707-35 · Lot# Exp Date: A2F03 · Exp Date: May-24
- Product Name: A2I02 · Package Description: Aug-24
- Product Name: A2L02 · Package Description: Nov-24
- Product Name: A3C04 · Package Description: Feb-25
- Product Name: A3H04 · Package Description: Jul-25
- Product Name: Lubricant PM Ointment · Package Description: 3.5 gram tube, packaged in cardboard box with UPC Code 371406124356 · Brand Name: AACE Pharmaceuticals · NDC: 71406- 124-35 · Lot# Exp Date: A2G01 · Exp Date: Jun-24
- Product Name: A2G02 · Package Description: Jun-24
- Product Name: A3F08 · Package Description: May-25
- Product Name: A3F09 · Package Description: May-25
- Product Name: A3J17 · Package Description: Sep-25
- Product Name: A3J18 · Package Description: Sep-25
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this voluntary recall and arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.
Consumers with questions regarding this recall can contact Brassica Pharma Pvt. Ltd. at +1 833-225-9564 or [email protected] . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.
Check your product
The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 681131395298
- 681131395304
- 050428634141
- 371406124356
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- A2E01
- Apr-24
- A2D08
- Mar-24
- A2F03
- May-24
- A2G01
- Jun-24
NDC number
On the carton and again on the bottle or blister label.
- 79903-026-35
Package size
Match the net weight or the piece count on the front of the pack.
- 3.5 gram
Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Sterility
Brassica Pharma Pvt. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
- If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
- Report any infection or reaction you think the product caused to FDA MedWatch.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: Brassica Pharma Pvt. Ltd. — Consumers: Brassica Pharma Pvt. Ltd, +1 833-225-9564, [email protected]
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Brassica Pharma Pvt. prescription & otc drugs recalled?
Due to Potential Lack of Sterility Assurance. Due to Potential Lack of Sterility Assurance.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 681131395298, 681131395304, 050428634141; best-by date A2E01 or Apr-24. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide, including at Walmart, CVS.
Related recalls
-
Class II · 12 days ago
Houston Rx LLC Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution recall: Lack of process control
Lack of process control
-
Class II · 12 days ago
Teva Pharmaceuticals USA, Inc Metoclopramide Tablets, USP, 5 mg recall: Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules
-
Class II · 12 days ago
American Health Packaging Metoclopramide Tablets, USP, 5 mg, 100 Tablets recall: Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules
-
Class II · 12 days ago
Zydus Pharmaceuticals Inc Hydrocortisone Sodium Succinate for Injection recall: Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications.
-
Class II · 12 days ago
Houston Rx LLC Tirzepatide/Niacinamide 2mL vial Inj 20mg/2mg/mL recall: Lack of assurance of sterility
Lack of assurance of sterility.
-
Class II · 19 days ago
K.C. Pharmaceuticals, Inc. Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility