Anticholinergic
Where is Tiotropium made?
2 companies sell it under their own name and 2 repackagers rebottle it. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. Spiriva Respimat, SpirivaHandiHaler1.562 ug, 3.124 ug, 18 ug · NDC 0597-0160, 0597-0075, 0597-0100 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.18 ug · NDC 68180-964 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Tiotropium 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.
- A-S Medication Solutions:
50090-4414,50090-4248,50090-7645 - Physicians Total Care, Inc.:
54868-5109
Recalls
- Jan 26, 2022 · Class II · Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Dec 14, 2017 · Class II · Boehringer Ingelheim Pharmaceuticals, Inc.
Failed Stability Specifications - Mar 27, 2014 · Class III · Boehringer Ingelheim Roxane Inc
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell. - Aug 30, 2013 · Class III · Boehringer Ingelheim Roxane Inc
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.