Status
Ongoing
Drug Enforcement D-0488-2023
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Classification
Class I
Report Date
March 29, 2023
Termination Date
—
Product Information
- 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.
- Product quantity
- 50,000 tubes
- Reason for recall
- Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
Location & Firm
- Recalling firm
- Global Pharma Healthcare Private Limited
- Address
-
A - 9 Sidco Pharmaceutical Complex, Thiruporur
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0488-2023
- Event ID
- 91768
- Recall initiation date
- February 24, 2023
- Center classification date
- March 30, 2023
- Code info
- Batch # H29, Exp. Date 11/30/2023
- More code info
- —