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traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Ph...

FDA Recall #D-0487-2024 — Class II — April 26, 2024

Recall #D-0487-2024 Date: April 26, 2024 Classification: Class II Status: Ongoing

Product Description

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

Recalling Firm

Rubicon Research Private Limited — Ambarnath, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,592 1000-count Bottles

Distribution

Nationwide in the USA

Code Information

Lot #: 230774Hl, Exp 4/30/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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