Boehringer Ingelheim Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
2
Inspections
16
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0468-2023Class IIJARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count March 9, 2023
D-0600-2021Class IIMicardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37May 4, 2021
D-0053-2021Class IICatapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: BoehriOctober 5, 2020
D-0051-2021Class IICatapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: BoehriOctober 5, 2020
D-0052-2021Class IICatapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: BoehriOctober 5, 2020
D-0991-2019Class IIIMirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton,March 7, 2019
D-0128-2019Class IICatapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer IOctober 22, 2018
D-1217-2018Class IISynjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottlSeptember 4, 2018
D-0242-2018Class IISPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blDecember 14, 2017
D-0007-2018Class IIIMobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer IngelheSeptember 22, 2017
D-0113-2017Class IIPersantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer IngelOctober 6, 2016
D-0114-2017Class IIDIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., ColOctober 6, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K863049INHALATION AIDOctober 15, 1986
K852277CATAPRESS TOURNIGUETJune 27, 1985