Boehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Foreign Particles
Boehringer Ingelheim is recalling SPIRIVA HandiHaler capsules due to potential foreign particles in the active pharmaceutical ingredient.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves potential foreign particles without reported injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules, 18 mcg per dose. The recall affects 15,385,232 capsules distributed nationwide in various blister pack sizes, including physician samples.
The recall is being conducted due to the potential for extrinsic foreign particles in the active pharmaceutical ingredient (API) used to manufacture the product. The source text does not specify the nature of the foreign particles or report any illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they are currently using the affected product.
The recalled product
- Product
- SPIRIVA (TIOTROPIUM BROMIDE)
- Brand
- SPIRIVA
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Hazard
- Affected units
- 15,385,232
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Number/Exp. Date: 202477A/Sep-13
- 202480A/Sep-13
- 202556B/Sep-13
- 202603A/Sep-13
- 202784B/Sep-13
- 202844A/Sep-13
- 202951A/Sep-13
- 203041A/Sep-13
- 203042A
- Sep-13
- 203280A/Oct-13
- 203281A/Oct-13
- 203364A/Oct-13
- 203440A
- Oct-13
- 203569B/Oct-13
- 203588A/Oct-13
- 203890B/Nov-13
- 204094A/Nov-13
- 203660A/Nov-13
Distribution
Distributed nationwide across the United States.
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