FDAFDA · Food and drugs·Recall number D-0487-2024
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
Published May 15, 2024 · Recall initiated: April 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TRAMADOL HYDROCHLORIDE
- Manufacturer
- Rubicon Research Private Limited
- Distributor
- Nationwide in the USA
- UPC
- 0372888163000
- Lot
- Lot #: 230774Hl, Exp 4/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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