NCS HealthCare of KY, Inc dba Vangard Labs
NDC labeler code: 0615
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Glimepiride3 products
- MirtazapineRemeronsoltab, Remeron · 2 products
- FenofibrateAntara, Lipofen, Tricor · 1 product
- NaproxenNaprelan, Rugby All Day Relief · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 20, 2018 | ANDA210138 | Fenofibrate FENOFIBRATE | Ajanta Pharma Ltd |
| June 29, 2012 | ANDA091220 | Glimepiride GLIMEPIRIDE | Micro Labs |
| October 22, 2004 | ANDA076921 | Mirtazapine MIRTAZAPINE | Aurobindo |
| December 18, 2001 | ANDA075927 | Naproxen NAPROXEN | Amneal Pharms Ny |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
October 27, 2023 · Class III · Terminated · D-0113-2024 · Buspirone
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
-
October 27, 2023 · Class III · Terminated · D-0114-2024 · Buspirone, Lisinopril
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026