Class II · Moderate risk
Spiriva Handihaler
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
National Drug Code
Is NDC 0597-0075-27 recalled?
Spiriva HandiHaler
Yes — this exact package was recalled
1 FDA recall names the code 0597-0075-27 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Tiotropium Bromide
- Strength
- TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1
- Form
- Capsule · Oral, Respiratory (inhalation)
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Type
- Human Prescription Drug
- Product code
- 0597-0075
Recalls naming this package
Class II · Moderate risk
Spiriva HandiHaler
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class III · Low risk
Spiriva HandiHaler
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.
Class III · Low risk
SPIRIVA HandiHaler
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
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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