Why it was recalled
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Product description
Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
Lot numbers, UPCs & expiration codes
AVK1175A, exp 9/2023
Where it was sold
Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141
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-0703-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Aug 18, 2021
- Quantity
- 2856 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0703-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88376
- Address
- 2 Independence Way
- Code information
- AVK1175A, exp 9/2023
- Postal code
- 08540-6620
- Report date
- Aug 18, 2021
- Product type
- Drugs
- Recall number
- D-0703-2021
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 2856 bottles
- Termination date
- Jun 8, 2023
- Reason for recall
- Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
- Distribution pattern
- Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2021