Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
Compare with the code on your package — it is the most precise check available.
Drug: Lisinopril Category: Blood Pressure Medication
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lisinopril and Hydrochlorothiazide NDC 68180-0519 |
HYDROCHLOROTHIAZIDE 12.5 mg/1; LISINOPRIL 20 mg/1 | Tablet Oral |
Lupin Pharmaceuticals, Inc. | Rx |
| Lisinopril and Hydrochlorothiazide NDC 70518-0382 |
HYDROCHLOROTHIAZIDE 12.5 mg/1; LISINOPRIL 20 mg/1 | Tablet Oral |
Remedyrepack INC. | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
CGMP Deviations
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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