Boehringer Ingelheim Roxane Inc: Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only,

Is my product affected?

Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by:

• Brand SPIRIVA

Check against the official notice below — it lists the full affected range.

What happened

Boehringer Ingelheim Roxane Inc. is recalling Spiriva HandiHaler (tiotropium bromide inhalation powder) 18 mcg capsules distributed nationwide and in Puerto Rico. The recall affects over 1.2 million blister cards across multiple lot numbers expiring between September 2014 and December 2014. The problem involves a defective delivery system where the drug powder may interact with lubricant inside the capsule shell, potentially causing doses to be delivered outside the specified amount.

The source document does not specify a remedy or recommended action for consumers who have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide and Puerto Rico Quantity: 1,276,710 Blister Cards Lot/code info: a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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