Recalls / Class II
Class IID-0600-2021
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
- Brand name
- Micardis
- Generic name
- Telmisartan
- Active ingredient
- Telmisartan
- Route
- Oral
- NDCs
- 0597-0040, 0597-0039, 0597-0041
- FDA application
- NDA020850
- Affected lot / code info
- Lot #860412; SEPT 2022
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 15,198 bottles (30 tablets per bottle)
- Distribution pattern
- AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR
Timeline
- Recall initiated
- 2021-05-04
- FDA classified
- 2021-05-28
- Posted by FDA
- 2021-06-09
- Terminated
- 2021-10-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0600-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.