Reported Jul 6, 2016 · Terminated

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx…

Lupin Pharmaceuticals Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174

Is this the product you have?

  • Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only
  • Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
  • Manufactured by
    • Lupin Limited Pithampur (M.P.) 454 775 India
    • a) NDC 68180-519-01
    • b) 68180-519-30
Lot codes and dates
    • Lot #: a) H303459
    • b) H303460
    • Exp 09/2016
Amount recalled
59,520 Bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 1, 2017 · Data as of Sep 19, 7:02 PM UTC

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