Recall: D-1052-2016

Class III - Minor Violations

Class IIIClassification

2016-04-04Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

Reason

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

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.