Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
Reason Presence of foreign substance: plastic-like substance.
Reason Failed Impurities/Degradation Specifications
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