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Recall Observatory FDA recall evidence

Drug product

Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.

D-1502-2016

April 06, 2016

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 74945
Status
Terminated
Classification
Class III
Quantity
20,556 bottles
Official record key
drug-enforcement:D-1502-2016

Official wording

Reason: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Code information: Batch number: H303487, H303488, H303489, Exp 09/16

Distribution pattern: All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations