# FDA recall D-1086-2023

> **ALEMBIC PHARMACEUTICALS, INC.** · Class III · drug recall initiated 2023-07-27.

## Product

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1086-2023
- **Recalling firm:** ALEMBIC PHARMACEUTICALS, INC.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-07-27
- **Report date:** 2023-08-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1086-2023

## Citation

> AI Analytics. FDA recall D-1086-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1086-2023. Source: US FDA. Licensed CC0.

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