FDAFDA · Food and drugs·Recall number D-0488-2023
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.
Published March 29, 2023 · Recall initiated: February 24, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Global Pharma Healthcare Private Limited
- Distributor
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
- Lot
- Batch # H29, Exp. Date 11/30/2023
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- India
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