Boehringer Ingelheim Recalls Perindopril Erbumine Tablets Due to Impurity
Boehringer Ingelheim Roxane Inc. is recalling 3,553 bottles of Perindopril Erbumine Tablets, 8mg, because out-of-specification results were found for impurity B.
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 the rubric associates with scores of 1 or 2. A score of 2 is assigned as it involves a pharmaceutical product with a quality deviation (impurity) rather than a purely cosmetic or documentation issue.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is voluntarily recalling 3,553 bottles of Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only. The product is identified by NDC 0054-0112-25, Lot #160017A, and an expiration date of 04/2013.
The recall was initiated because out-of-specification results were found for impurity B, which is identified as the drug's metabolite. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,553
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 (2)
- Lot #160017A
- Exp 04/2013.
Distribution
Distributed nationwide across the United States.
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