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 Indiaa) NDC 68180-519-01b) 68180-519-30
- Lot codes and dates
Lot #: a) H303459b) H303460Exp 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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