# FDA recall D-0642-2024

> **FDC Limited** · Class II · drug recall initiated 2024-08-12.

## Product

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

## Reason for recall

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

## Distribution

Nationwide U.S.A.

## Key facts

- **Recall number:** D-0642-2024
- **Recalling firm:** FDC Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-08-12
- **Report date:** 2024-08-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0642-2024

## Citation

> AI Analytics. FDA recall D-0642-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0642-2024. Source: US FDA. Licensed CC0.

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