Venlafaxine Hydrochloride Extended-Release Capsules recall

Why it was recalled

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

Details

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

Recalling company

Zydus Pharms USA

Classification

Class II

Status

Terminated

Type

Voluntary: Firm initiated

Distribution

Nationwide within the United States

Initiated

Jun 21, 2024

FDA report date

Jul 31, 2024