Global Pharma Healthcare Private Limited: Drug Recall

Recall #D-0488-2023 · 02/24/2023

Class I: Dangerous

Recall Details

Recall Number: D-0488-2023
Classification: Class I
Product Type: Drug
Recalling Firm: Global Pharma Healthcare Private Limited
Status: Ongoing
Date Initiated: 02/24/2023
Location: Chennai, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50,000 tubes

Reason for Recall

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.

Distribution Pattern

Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.

Other Recalls by Global Pharma Healthcare Private Limited

Class I: Dangerous 01/30/2023

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class I: Dangerous 01/30/2023

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class II: Risk 01/30/2023

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Class II: Risk 01/30/2023

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

View all recalls by Global Pharma Healthcare Private Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.