Micardis
FDA Recall NDC 0597-0039
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Micardis (NDC 0597-0039). A significant event, classified as Class II, was initiated on May 04, 2021 by Boehringer Ingelheim Pharmaceuticals, Inc.. The reported reason for this action was: "Subpotent Drug"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent Drug
May 04, 2021
Jun 09, 2021
15,198 bottles (30 tablets per bottle)
Recall Profile & Regulatory Data
Event ID
87856
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR
Termination Date
Oct 14, 2021
Product Description
Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
Batch or Lot Expiration Information
Lot# 860412; SEPT 2022
Affected Packages Involved in this Recall
0597-0039-37Product
0597-0040-37Product
0597-0041-37Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
