Drug Enforcement D-202-2013

Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.

Status

Terminated

Classification

Class II

Report Date

April 3, 2013

Termination Date

May 4, 2015

Product Information

Product description
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
Product quantity
13,320 bottles
Reason for recall
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Zydus Pharmaceuticals USA Inc
Address
73 Route 31 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-202-2013
Event ID
64604
Recall initiation date
March 5, 2013
Center classification date
March 25, 2013
Code info
Lot #: MM8490, Exp 09/14
More code info
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