Boehringer Ingelheim Recalls Pradaxa 75 mg Capsules Due to Defective Containers
Boehringer Ingelheim is recalling 8,381 bottles of Pradaxa 75 mg capsules because defective containers may allow moisture to enter, potentially impairing product quality.
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 II, and the hazard involves potential quality impairment due to moisture ingress without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling 8,381 bottles of Pradaxa (dabigatran etexilate) 75 mg capsules, 60 count bottles. The affected product is identified by Lot 201900 with an expiration date of JAN 2015. The product was distributed nationwide.
The recall was initiated because defective containers and damaged bottles could allow moisture to get into the bottle. This exposure to moisture may impair the quality of the product.
Consumers with this specific lot of Pradaxa should contact their healthcare provider or pharmacist for further instructions on how to proceed.
The recalled product
- Product
- Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Anticoagulant
- Affected units
- 8,381
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 (1)
- Lot 201900 Expiration Date: JAN 2015
Distribution
Distributed nationwide across the United States.
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