# FDA recall D-0488-2024

> **FDC Limited** · Class II · drug recall initiated 2024-04-25.

## Product

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

## Reason for recall

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

## Distribution

New Jersey Only

## Key facts

- **Recall number:** D-0488-2024
- **Recalling firm:** FDC Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2024-04-25
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aurangabad, Maharashtra State, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2024

## Citation

> AI Analytics. FDA recall D-0488-2024. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0488-2024. Source: US FDA. Licensed CC0.

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