Why it was recalled
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 230774Hl, Exp 4/30/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0487-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 26, 2024
- FDA report date
- May 15, 2024
- Quantity
- 2,592 1000-count Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rubicon Research Private Limited
Original FDA data
Every field from FDA enforcement report D-0487-2024, exactly as published.
Show all FDA fields
- City
- Ambarnath
- Status
- Ongoing
- Country
- India
- Event ID
- 94467
- Address
- 4 & K30 5 Plot No K - 30
- Address (line 2)
- District
- Code information
- Lot #: 230774Hl, Exp 4/30/2026
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0487-2024
- Classification
- Class II
- Recalling firm
- Rubicon Research Private Limited
- Product quantity
- 2,592 1000-count Bottles
- Reason for recall
- Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 26, 2024
- Initial firm notification
- Letter
- Center classification date
- May 7, 2024