SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Reported: September 25, 2013 Initiated: August 30, 2013 #D-1057-2013
Product Description
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Reason for Recall
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
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 15,385,232 capsules
- Distribution
- Nationwide
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 15,385,232 capsules.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 25, 2013. Severity: Low. Recall number: D-1057-2013.
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