Why it was recalled
Packaging defect: blister packaging inadequately sealed.
Product description
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Lot numbers, UPCs & expiration codes
Lot #: M04343, Exp. 04/2024
Where it was sold
Nationwide in the U.S.
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-0878-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2023
- FDA report date
- Jul 5, 2023
- Quantity
- 3876 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0878-2023, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 92524
- Address
- 341 Mason Rd
- Code information
- Lot #: M04343, Exp. 04/2024
- Postal code
- 37086-3606
- Report date
- Jul 5, 2023
- Product type
- Drugs
- Recall number
- D-0878-2023
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 3876 cartons
- Termination date
- Apr 30, 2024
- Reason for recall
- Packaging defect: blister packaging inadequately sealed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jun 16, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2023