Why it was recalled
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Product description
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Lot numbers, UPCs & expiration codes
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Where it was sold
Nationwide within the United States
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-0617-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2024
- FDA report date
- Jul 31, 2024
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0617-2024, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94850
- Address
- 73 Route 31 N
- Code information
- Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
- Postal code
- 08534-3601
- Report date
- Jul 31, 2024
- Product type
- Drugs
- Recall number
- D-0617-2024
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- a) 13,128 bottles; b) 252 bottles
- Termination date
- Aug 6, 2025
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 21, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2024