FDAFDA · Food and drugs·Recall number D-0617-2024
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
Published July 31, 2024 · Recall initiated: June 21, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VENLAFAXINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide within the United States
- UPC
- 0368382034106
- Lot
- Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.