Opioid Agonist/Antagonist
Where is Nalbuphine made?
2 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 2 factories in the United States and India.
United States 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc.10 mg per 1 mL, 20 mg per 1 mL · NDC 0409-1463, 0409-1464, 0409-1465 +1 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Somerset Therapeutics, LLC10 mg per 1 mL, 20 mg per 1 mL · NDC 70069-661, 70069-671, 70069-662 +1 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
Repackaged by
These companies buy Nalbuphine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- HF Acquisition Co. LLC. DBA HealthFirst:
51662-1420,51662-1418 - Henry Schein, Inc.:
0404-9919,0404-9918,0404-9767,0404-9917+1 - Medical Purchasing Solutions, LLC.:
71872-7114,71872-7331,71872-7320 - ProPharma Distribution:
84549-464
Recalls
- Nov 21, 2012 · Class II · Hospira, Inc.
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.