Covis Pharma US, Inc
NDC labeler code: 70515
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
- DigoxinLanoxin · 4 products
- TizanidineZanaflex, Ontralfy · 4 products
- NisoldipineSular · 3 products
- CiclesonideAlvesco, Omnaris · 3 products
- OmeprazolePrilosec · 2 products
- Aclidinium bromide and formoterol fumarateDuaklir Pressair · 1 product
- Aclidinium bromideTudorza Pressair · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 29, 2019 | NDA210595 | Aclidinium bromide and formoterol fumarate DUAKLIR PRESSAIR | Azurity |
| July 23, 2012 | NDA202450 | Aclidinium bromide TUDORZA PRESSAIR | Azurity |
| March 20, 2008 | NDA022056 | Omeprazole PRILOSEC | Azurity |
| January 10, 2008 | NDA021658 | Ciclesonide ALVESCO | Azurity |
| October 20, 2006 | NDA022004 | Ciclesonide OMNARIS | Azurity |
| August 29, 2002 | NDA021447 | Tizanidine ZANAFLEX | Legacy |
| November 27, 1996 | NDA020397 | Tizanidine ZANAFLEX | Legacy |
| February 2, 1995 | NDA020356 | Nisoldipine SULAR | Azurity |
| November 16, 1954 | NDA009330 | Digoxin LANOXIN, LANOXIN PEDIATRIC | Azurity |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2021
-
March 15, 2021 · Class II · Terminated · D-0466-2021 · Omeprazole
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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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