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Boehringer Ingelheim Roxane Recalls
15 recalls on record · December 5, 2012 to October 21, 2015 · Drugs
Recalls by year
12
13
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 21, 2015DrugsFDA
Boehringer Ingelheim Roxane Inc recalls FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories
Hazard: CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
October 21, 2015DrugsFDA
Boehringer Ingelheim Roxane Inc recalls FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories
Hazard: CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
August 5, 2015DrugsFDA
Boehringer Ingelheim Roxane Inc recalls COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Met
Hazard: Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
June 3, 2015DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories,
Hazard: Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
August 6, 2014DrugsFDA
Boehringer Ingelheim Roxane Inc recalls OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratori
Hazard: Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
July 16, 2014DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-
Hazard: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
May 14, 2014DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
May 14, 2014DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
April 16, 2014DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only
Hazard: Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
December 18, 2013DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054
Hazard: SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
November 27, 2013DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Colu
Hazard: Resuspension Problems: Recalled lot did not meet resuspendability requirements.
September 25, 2013DrugsFDA
Boehringer Ingelheim Roxane Inc recalls SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 05
Hazard: Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
August 21, 2013DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per c
Hazard: Labeling: Missing Label; missing label on blister card
January 23, 2013DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Colu
Hazard: Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
December 5, 2012DrugsFDA
Boehringer Ingelheim Roxane Inc recalls Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceu
Hazard: Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product