Class II
Ongoing
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
This recall is currently active, issued May 15, 2024. It was issued by Rubicon Research Private Limited.
- Company
- Rubicon Research Private Limited
- Recall Initiated
- April 26, 2024
- Posted
- May 15, 2024
- Recall Number
- D-0487-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,592 1000-count Bottles
- Firm Location
- Ambarnath, India
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot #: 230774Hl, Exp 4/30/2026
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