D-0488-2023 Class I Ongoing
FDA drug recall D-0488-2023 was initiated by Global Pharma Healthcare Private Limited on Feb 24, 2023 and is designated Class I. Reason for recall: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. The recall status is ongoing. Affected quantity: 50,000 tubes.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 29, 2023
- Initiation Date
- Feb 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,000 tubes
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.
Reason for recall
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Distribution pattern
Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Code information
Batch # H29, Exp. Date 11/30/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0488-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026