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RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals Inc. has initiated a nationwide voluntary recall of a single manufacturing lot of Pradaxa, an anticoagulant.
The company said Wednesday that it’s recalling the lot — Pradaxa (dabigatran etexilate mesylate, 75mg) 60 US, NDC 0597- 0149-54, lot 201900, expiration January 2015 — because a packaging defect could allow moisture to get into the bottle and possibly impair the quality of the anti-clotting medication.
"As a consequence, a patient may not receive a fully effective dose of Pradaxa 75mg, which would increase his or her risk of experiencing an ischemic stroke," Boehringer Ingelheim stated. "This risk is small — however, not zero. Therefore, as a precautionary measure, Pradaxa is being recalled at the patient level."
According to the company, information about the recall has been sent to pharmacists, and those who may have dispensed Pradaxa capsules to patients from the affected manufacturing lot (No. 201900) are being instructed to contact those patients to return the product lot back to the pharmacy.
"Patients should continue to take the product as directed until they obtain replacement to assure there is no interruption of therapy," Boehringer Ingelheim said. "We believe most of the potentially affected bottles have been returned, but if a person has or receives a bottle of Pradaxa 75mg from the potentially affected lot, he/she should return the potentially affected bottle to their pharmacist as soon as possible for replacement at no charge."
A medication for preventing blood clots, Pradaxa is used to reduce the risk of stroke in people with nonvalvular atrial fibrillation, a type of heart rhythm disorder.
