FDAHealthJune 21, 2024
Zydus Pharmaceuticals (USA) Inc — 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 on
⚠️ Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 21, 2024
Nationwide within the United States
What's affected?
- Product
- 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
- UPC
- 0368382034106
- Lot code
- a)
Additional details
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: a) 13,128 bottles; b) 252 bottles.
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