Recalls / Class II
Class IID-0487-2024
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
- Brand name
- Tramadol Hydrochloride
- Generic name
- Tramadol Hydrochloride
- Active ingredient
- Tramadol Hydrochloride
- Route
- Oral
- NDCs
- 72888-008, 72888-162, 72888-080, 72888-163
- FDA application
- ANDA208708
- Affected lot / code info
- Lot #: 230774Hl, Exp 4/30/2026
Why it was recalled
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Recalling firm
- Firm
- Rubicon Research Private Limited
- Manufacturer
- Advagen Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4 & K30 5 Plot No K - 30, District, Ambarnath, N/A N/A, India
Distribution
- Quantity
- 2,592 1000-count Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-04-26
- FDA classified
- 2024-05-07
- Posted by FDA
- 2024-05-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0487-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.