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Recall Observatory FDA recall evidence

Drug product

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01

D-1036-2016

May 25, 2016

Class III

Product summary

Firm
Sandoz Inc
Event
Event 74326
Status
Terminated
Classification
Class III
Quantity
3,048 bottles ( 304,800 tablets)
Official record key
drug-enforcement:D-1036-2016

Official wording

Reason: Labeling: Incorrect or Missing Package Insert

Code information: Lot # FC1960; Exp.: 02/18

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing