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Recall Observatory FDA recall evidence

Drug product

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

D-0600-2021

May 04, 2021

Class II

Product summary

Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Event
Event 87856
Status
Terminated
Classification
Class II
Quantity
15,198 bottles (30 tablets per bottle)
Official record key
drug-enforcement:D-0600-2021

Official wording

Reason: Subpotent Drug

Code information: Lot #860412; SEPT 2022

Distribution pattern: AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent