Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed B
Summary
The FDA issued a Class I for Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), by Global Pharma Healthcare Private Limited. Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria..
Details
Source
Drug Recall
External ID
D-0488-2023
Action Date
2023-03-29
Status
Ongoing
Category
drug
Product Description
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
Lot/Code Info: Batch # H29, Exp. Date 11/30/2023
Quantity Affected: 50,000 tubes
Reason for Recall
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Distribution
Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-24
Company
Chennai, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Global Pharma Healthcare Private Limited has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Global Pharma Healthcare Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Global Pharma Healthcare Private Limited have FDA actions?
Global Pharma Healthcare Private Limited has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0488-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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