Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product type
Drug
Status
Terminated
Report date
2024-07-31
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
a) 13,128 bottles; b) 252 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
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
Code / lot info
Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.