# FDA recall D-0488-2023

> **Global Pharma Healthcare Private Limited** · Class I · drug recall initiated 2023-02-24.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** D-0488-2023
- **Recalling firm:** Global Pharma Healthcare Private Limited
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-02-24
- **Report date:** 2023-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chennai, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2023

## Citation

> AI Analytics. FDA recall D-0488-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0488-2023. Source: US FDA. Licensed CC0.

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