Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by
Summary
The FDA issued a Class II for Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), by Brassica Pharma Pvt Ltd. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0352-2024
Action Date
2024-03-06
Status
Ongoing
Category
drug
Product Description
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Lot/Code Info: Lot #: A2D08, Exp. Date Mar-24; A2F02, Exp. Date May-24; A2I03, Exp. Date Aug-24; A2L03, A2L04, Exp. Date Nov-24; A3C03, A3C05, Exp. Date Feb-25 A3H01, A3H03, Exp. Date Jul-25
Quantity Affected: 355,633 units
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-30
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 63 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Brassica Pharma Pvt Ltd has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Brassica Pharma Pvt Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brassica Pharma Pvt Ltd have FDA actions?
Brassica Pharma Pvt Ltd has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0352-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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