FDA-Drug2024-05-15Class II
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
Rubicon Research Private Limited
Hazard
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Sold states
Nationwide in the USA
Affected count
2,592 1000-count Bottles
Manufactured in
4 & K30 5 Plot No K - 30, District, Ambarnath, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0487-2024Don't want to check this manually?
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