Global Pharma Healthcare Private Limited: Drug Recall

Recall #D-0919-2023 · 01/30/2023

Class I: Dangerous

Recall Details

Recall Number: D-0919-2023
Classification: Class I
Product Type: Drug
Recalling Firm: Global Pharma Healthcare Private Limited
Status: Ongoing
Date Initiated: 01/30/2023
Location: Chennai, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 400,008 bottles total for all products

Reason for Recall

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Product Description

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

Distribution Pattern

Product was distributed to two distributors who further distributed Nationwide in the USA.

Other Recalls by Global Pharma Healthcare Private Limited

Class I: Dangerous 02/24/2023

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
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.