AbbVie Recalls Mavik Trandolapril Tablets Due to Outdated Package Insert
AbbVie is recalling 704 bottles of Mavik trandolapril tablets 4mg because they were packaged with an outdated version of the package insert.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (outdated insert) rather than a product defect or contamination.
Plain-English summary
AbbVie Inc. is recalling 704 bottles of Mavik trandolapril tablets 4mg, 100 count, Rx only. The product was manufactured by Halo Pharmaceutical Inc. for Abbott Laboratories. The recall is limited to Lot 22033GY.
The recall was initiated because the product was packaged with an outdated version of the package insert. This is a labeling issue regarding the documentation provided with the medication.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 704
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 22033GY
Distribution
Distributed nationwide across the United States.
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