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.
Reported: March 29, 2023 Initiated: February 24, 2023 #D-0488-2023
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.
Details
- Recalling Firm
- Global Pharma Healthcare Private Limited
- Units Affected
- 50,000 tubes
- Distribution
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
- Location
- Chennai, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Global Pharma Healthcare Private Limited. Units affected: 50,000 tubes.
Why was this product recalled? ▼
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 29, 2023. Severity: Critical. Recall number: D-0488-2023.
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