Drug recall
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle…
FDA recall event 91621 · Class I, Class II · Global Pharma Healthcare Private Limited
Key facts
| Event ID | 91621 |
|---|---|
| Recall numbers | D-0919-2023, D-0920-2023, D-0921-2023, D-0922-2023 |
| Recalling firm | Global Pharma Healthcare Private Limited |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I, Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | 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…, Non-Sterility: FDA analysis found unopened products to have bacterial contamination. |
| Initiation date | Jan 30, 2023 |
| Report date | Jul 19, 2023 |
| City | Chennai |
| Country | India |
| FEI number | 3012323885 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: