Recalls / Class II
Class IID-0703-2021
Product
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
- Affected lot / code info
- AVK1175A, exp 9/2023
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
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 2856 bottles
- Distribution pattern
- Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-06
- Posted by FDA
- 2021-08-18
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0703-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.