Boehringer Ingelheim Roxane recalls

Boehringer Ingelheim Roxane appears in 15 official U.S. recall notices indexed by RecallRadar, most recently on 2015-10-21.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O…
  FDA Drug · Class III · 2015-10-21 · Boehringer Ingelheim Roxane
  Reason: 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.
• FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, O…
  FDA Drug · Class III · 2015-10-21 · Boehringer Ingelheim Roxane
  Reason: 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.
• COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inha…
  FDA Drug · Class II · 2015-08-05 · Boehringer Ingelheim Roxane
  Reason: Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
• Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc
  FDA Drug · Class II · 2015-06-03 · Boehringer Ingelheim Roxane
  Reason: Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
• OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only
  FDA Drug · Class III · 2014-08-06 · Boehringer Ingelheim Roxane
  Reason: Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
• Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41
  FDA Drug · Class II · 2014-07-16 · Boehringer Ingelheim Roxane
  Reason: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
• Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
  FDA Drug · Class III · 2014-05-14 · Boehringer Ingelheim Roxane
  Reason: 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.
• Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
  FDA Drug · Class III · 2014-05-14 · Boehringer Ingelheim Roxane
  Reason: 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.
• Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotro…
  FDA Drug · Class III · 2014-04-16 · Boehringer Ingelheim Roxane
  Reason: 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.
• Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 10…
  FDA Drug · Class III · 2013-12-18 · Boehringer Ingelheim Roxane
  Reason: SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
• Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc
  FDA Drug · Class II · 2013-11-27 · Boehringer Ingelheim Roxane
  Reason: Resuspension Problems: Recalled lot did not meet resuspendability requirements.
• SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30…
  FDA Drug · Class III · 2013-09-25 · Boehringer Ingelheim Roxane
  Reason: 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
• Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Col…
  FDA Drug · Class III · 2013-08-21 · Boehringer Ingelheim Roxane
  Reason: Labeling: Missing Label; missing label on blister card
• Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC…
  FDA Drug · Class III · 2013-01-23 · Boehringer Ingelheim Roxane
  Reason: Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
• Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridge…
  FDA Drug · Class II · 2012-12-05 · Boehringer Ingelheim Roxane
  Reason: Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product