Chloride Channel Activator
Where is Lubiprostone made?
12 companies sell it under their own name and 12 repackagers rebottle it. Their labels name 3 factories in the United States and India.
United States 2India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascent Pharmaceuticals, Inc.0.008 mg, 0.024 mg · NDC 43602-548, 43602-549 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Cadila Healthcare Limited8 ug, 24 ug · NDC 70771-1764, 70771-1763 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.0.008 mg, 0.024 mg · NDC 31722-403, 31722-404 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Caraco Pharmaceutical Laboratories, Ltd.8 ug, 24 ug · NDC 63304-352, 63304-351 | Catalent Pharma Solutions, LLCMakes it and tests it | St Petersburg, FL, United States | Problems found, fixed voluntarilyJan 2026 |
| Northstar Rx LLC.0.008 mg, 0.024 mg · NDC 72603-288, 72603-289 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Zydus Pharmaceuticals (USA) Inc.8 ug, 24 ug · NDC 70710-1642, 70710-1641 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Amneal Pharmaceuticals8 ug, 24 ug · NDC 65162-842, 65162-841 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.8 ug, 24 ug · NDC 43598-168, 43598-163 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ENDO USA, Inc.8 ug, 24 ug · NDC 0254-3029, 0254-3028 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SpecGx LLC Amitiza8 ug, 24 ug · NDC 0406-6424, 23635-524, 0406-6408 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Takeda Pharmaceuticals America, Inc. Amitiza8 ug, 24 ug · NDC 64764-240, 64764-080 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.8 ug, 24 ug · NDC 0480-4138, 0480-3479 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Lubiprostone 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.
- Advanced Rx Pharmacy of Tennessee, LLC:
80425-0355,80425-0354 - American Health Packaging:
60687-827,60687-816 - Asclemed USA, Inc.:
76420-907,76420-778,76420-906,76420-777 - AvKARE, Inc.:
42291-476,42291-475 - Carilion Materials Management:
68151-5003 - Direct Rx:
72189-607,72189-410 - Golden State Medical Supply, Inc.:
51407-745,51407-744 - Lake Erie Medical DBA Quality Care Products LLC:
55700-963 - Natco Pharma USA LLC:
69339-163,69339-162 - Physicians Total Care, Inc.:
54868-5971,54868-6153 - Proficient Rx LP:
71205-834,71205-832,82804-001,82804-304+1 - Stat Rx USA:
16590-622
Recalls
- May 13, 2019 · Class II · Mallinckrodt Pharmaceuticals · 2 recall notices
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is bein… - Nov 6, 2018 · Class III · Takeda Development Center Americas, Inc.
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.