The Recall Desk

FDA (Drugs) recall action 86527

Boehringer Ingelheim Pharmaceuticals, Inc. recalled 3 products on 2020-11-04

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-11-04
Critical
0
Units

Why these products were recalled

An extraneous peak was observed for dissolution testing.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling specific lots of Catapres tablets because an extraneous peak was observed during dissolution testing.

    Product
    Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling specific Catapres tablets because an extraneous peak was observed during dissolution testing. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling Catapres tablets because an extraneous peak was observed during dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.

    Product
    Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
    Category
    Distribution
    1 state