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Recall Observatory FDA recall evidence

Drug product

Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60

D-1325-2015

August 03, 2015

Class II

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 71906
Status
Terminated
Classification
Class II
Quantity
2,952 bottles
Official record key
drug-enforcement:D-1325-2015

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot #: C501342; Exp 01/2017

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications