Chennai, N/A, India
Global Pharma Healthcare Private Limited recalls
2 recalls recorded since 2018, most recently on 24 February 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)2
Ongoing Class I Drugs
- Recall started
- 24 February 2023
- Reason
- Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
- Distribution
- Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0488-2023
- 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.
Ongoing Class I, Class II Drugs
- Recall started
- 30 January 2023
- Reason
- Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
- Distribution
- Product was distributed to two distributors who further distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0919-2023, D-0921-2023, D-0920-2023, D-0922-2023
- 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.
- Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
- 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.
- Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.