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Recall Observatory FDA recall evidence

Drug product

Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01

D-1516-201

March 24, 2016

Class III

Product summary

Firm
Lupin Limited
Event
Event 74944
Status
Terminated
Classification
Class III
Quantity
3,192 bottles (319,200 tablets)
Official record key
drug-enforcement:D-1516-201

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Expiration Date

Code information: Lot # G510086; Exp. 11/17

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing