# FDA recall D-0487-2024

> **Rubicon Research Private Limited** · Class II · drug recall initiated 2024-04-26.

## Product

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

## Reason for recall

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0487-2024
- **Recalling firm:** Rubicon Research Private Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-04-26
- **Report date:** 2024-05-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0487-2024

## Citation

> AI Analytics. FDA recall D-0487-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0487-2024. Source: US FDA. Licensed CC0.

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