# FDA recall D-0259-2024

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2024-01-04.

## Product

Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56

## Reason for recall

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0259-2024
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-01-04
- **Report date:** 2024-01-31
- **Termination date:** 2024-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0259-2024

## Citation

> AI Analytics. FDA recall D-0259-2024. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/D-0259-2024. Source: US FDA. Licensed CC0.

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