May 2021 FDA Recall Micardis by Boehringer Ingelheim Pharmaceuticals, Inc.
D-0600-2021 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on May 4, 2021 for the product Micardis. The FDA reported the reason for recall as subpotent drug. The product was distributed in AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR and the recall is currently terminated.
Recall Number: D-0600-2021
Subpotent Drug
05-04-2021
06-09-2021
15,198 bottles (30 tablets per bottle)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR
10-14-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 860412; SEPT 2022
