Boehringer Ingelheim Roxane Inc

Complete recall history across all FDA and CPSC categories — 15 total recalls

Boehringer Ingelheim Roxane Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (15)

FDA drug safety enforcement actions by Boehringer Ingelheim Roxane Inc

Date Product Reason Class
Sep 25, 2015 FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use ... Class III
Sep 25, 2015 FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... CGMP Deviations: The active pharmaceutical ingredient (API) intended for use ... Class III
Jul 24, 2015 COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 m... Defective Delivery System: Inhalers do not spray properly, emitting either no... Class II
Apr 2, 2015 Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... Subpotent Drug: The firm received an out of specification result for Assay (p... Class II
Jul 28, 2014 OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... Failed Stability Specifications: Out of specification result for preservative... Class III
May 1, 2014 Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... Failed Impurity/Degradation Specification; out of specification for trans-cal... Class II
Apr 4, 2014 Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being cond... Class III
Apr 4, 2014 Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being cond... Class III
Mar 27, 2014 Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spi... Defective Delivery System: Potential for dose delivery out of specification d... Class III
Aug 30, 2013 SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per... Presence of Foreign Substance: This recall is being conducted due to the pote... Class III
Jun 14, 2013 Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablet... Labeling: Missing Label; missing label on blister card Class III
Apr 3, 2013 Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringe... Resuspension Problems: Recalled lot did not meet resuspendability requirements. Class II
Mar 18, 2013 Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets... SubPotent Drug: The firm discovered out of specification results for assay an... Class III
Dec 12, 2012 Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringe... Impurities/Degradation Products: Out of Specification results found for impur... Class III
Nov 5, 2012 Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Di... Defective container; damaged bottles could allow moisture to get into the bot... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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