Drug 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
D-0487-2024
Product summary
- Event
- Event 94467
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,592 1000-count Bottles
- Official record key
drug-enforcement:D-0487-2024
Official wording
Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Code information: Lot #: 230774Hl, Exp 4/30/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets