TerSera Therapeutics LLC
NDC labeler code: 70720
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
- Ziconotide acetatePrialt · 3 products
- GoserelinZoladex · 2 products
- Telotristat ethylXermelo · 1 product
- Margetuximab-cmkbMargenza · 1 product
- CetirizineQuzyttir, Zerviate · 1 product
- RolapitantVarubi · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 16, 2020 | BLA761150 | Margetuximab-cmkb MARGENZA | Tersera Therapeutics LLC |
| October 4, 2019 | NDA211415 | Cetirizine QUZYTTIR | Esteve |
| February 28, 2017 | NDA208794 | Telotristat ethyl XERMELO | Tersera |
| September 1, 2015 | NDA206500 | Rolapitant VARUBI | Tersera |
| December 28, 2004 | NDA021060 | Ziconotide acetate PRIALT | Esteve |
| January 11, 1996 | NDA020578 | Goserelin ZOLADEX | Tersera |
| December 29, 1989 | NDA019726 | Goserelin ZOLADEX | Tersera |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
August 31, 2026 · Class II · Ongoing · D-0875-2026 · Goserelin
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Sw
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