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Recall Observatory FDA recall evidence

Drug product

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.

D-202-2013

March 05, 2013

Class II

Product summary

Firm
Zydus Pharmaceuticals USA Inc
Event
Event 64604
Status
Terminated
Classification
Class II
Quantity
13,320 bottles
Official record key
drug-enforcement:D-202-2013

Official wording

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

Code information: Lot #: MM8490, Exp 09/14

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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