Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
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 Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
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 |
|---|---|---|---|---|
| Buspirone Hydrochloride NDC 00615-7718 |
10 mg/1 | Tablet Oral |
NCS HealthCare of KY, LLC dba Vangard Labs | Rx |
| Lisinopril NDC 00615-8255 |
20 mg/1 | Tablet Oral |
NCS HealthCare of KY, LLC dba Vangard Labs | Rx |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 Substance: Foreign material (metal piece) embedded in one tablet.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
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