Why it was recalled
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Product description
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
Lot numbers, UPCs & expiration codes
Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
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-0489-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2024
- FDA report date
- May 15, 2024
- Quantity
- 23,970 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0489-2024, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 94567
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
- Postal code
- 15701-3571
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0489-2024
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 23,970 Tablets
- Termination date
- Sep 9, 2024
- Reason for recall
- Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 2, 2024
- Initial firm notification
- Center classification date
- May 8, 2024