Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Particulate Matter
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
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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