D-0617-2024 Class II Terminated
FDA drug recall D-0617-2024 was initiated by Zydus Pharmaceuticals (USA) Inc on Jun 21, 2024 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. The recall status is terminated (terminated Aug 6, 2025). Affected quantity: a) 13,128 bottles; b) 252 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 31, 2024
- Initiation Date
- Jun 21, 2024
- Termination Date
- Aug 6, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 13,128 bottles; b) 252 bottles
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
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0617-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026