Prescription drug
Where is Pancrelipase Amylase and Pancrelipase Lipase and Pancrelipase Protease made?
4 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 2 factories in the United States and Germany.
United States 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Digestive Care, Inc. Pertzye4000 [USP'U] / 14375 [USP'U] / 15125 [USP'U], 8000 [USP'U] / 28750 [USP'U] / 30250 [USP'U], 16000 [USP'U] / 57500 [USP'U] / 60500 [USP'U], 24000 [USP'U] / 86250 [USP'U] / 90750 [USP'U] · NDC 59767-016, 59767-024, 59767-004 +1 | Digestive Care, Inc.Makes it | Bethlehem, PA, United States | Problems found, fixed voluntarilyMay 2026 |
| Vivus LLC Pancreaze2600 [USP'U] / 8800 [USP'U] / 15200 [USP'U], 4200 [USP'U] / 14200 [USP'U] / 24600 [USP'U], 10500 [USP'U] / 35500 [USP'U] / 61500 [USP'U], 16800 [USP'U] / 56800 [USP'U] / 98400 [USP'U], 21000 [USP'U] / 54700 [USP'U] / 83900 [USP'U], 37000 [USP'U] / 97300 [USP'U] / 149900 [USP'U] · NDC 62541-403, 62541-404, 62541-405 +3 | Nordmark Pharma GmbHMakes it, makes the active ingredient and tests it | Uetersen, Germany | Problems found, fixed voluntarilyFeb 2025 |
| AbbVie Inc. Creon3000 [USP'U] / 9500 [USP'U] / 15000 [USP'U], 6000 [USP'U] / 19000 [USP'U] / 30000 [USP'U], 12000 [USP'U] / 38000 [USP'U] / 60000 [USP'U], 24000 [USP'U] / 76000 [USP'U] / 120000 [USP'U], 36000 [USP'U] / 114000 [USP'U] / 180000 [USP'U] · NDC 0032-1212, 0032-0047, 0032-1224 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Aimmune Therapeutics, Inc. Zenpep, Viokace3000 [USP'U] / 10000 [USP'U] / 14000 [USP'U], 5000 [USP'U] / 17000 [USP'U] / 24000 [USP'U], 10000 [USP'U] / 32000 [USP'U] / 42000 [USP'U], 10440 [USP'U] / 39150 [USP'U], 15000 [USP'U] / 47000 [USP'U] / 63000 [USP'U], 20000 [USP'U] / 63000 [USP'U] / 84000 [USP'U] · NDC 73562-110, 73562-104, 73562-111 +7 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Pancrelipase Amylase and Pancrelipase Lipase and Pancrelipase Protease 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.
- Atlantic Biologicals Corps.:
17856-1212,17856-1224,17856-1206 - Physicians Total Care, Inc.:
54868-6435,54868-6067
Recalls
- Jun 23, 2023 · Class III · Vivus, Inc.
Failed Stability Specifications - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Sep 15, 2014 · Class II · AbbVie Inc
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.