Why it was recalled
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
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 numbers, UPCs & expiration codes
Batch # H29, Exp. Date 11/30/2023
Where it was sold
Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0488-2023
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Feb 24, 2023
- FDA report date
- Mar 29, 2023
- Quantity
- 50,000 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Pharma Healthcare Private Limited
Original FDA data
Every field from FDA enforcement report D-0488-2023, exactly as published.
Show all FDA fields
- City
- Chennai
- Status
- Ongoing
- Country
- India
- Event ID
- 91768
- Address
- A - 9 Sidco Pharmaceutical Complex
- Address (line 2)
- Thiruporur
- Code information
- Batch # H29, Exp. Date 11/30/2023
- Report date
- Mar 29, 2023
- Product type
- Drugs
- Recall number
- D-0488-2023
- Classification
- Class I
- Recalling firm
- Global Pharma Healthcare Private Limited
- Product quantity
- 50,000 tubes
- Reason for recall
- Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
- Recall initiation date
- Feb 24, 2023
- Initial firm notification
- Press Release
- Center classification date
- Mar 30, 2023