Boehringer Ingelheim Roxane recalls
FDA enforcement reports naming Boehringer Ingelheim Roxane Inc as the recalling firm.
- Recall reports
- 15
- Class I (serious)
- 0
- Most recent report
- Oct 21, 2015
- Oct 21, 2015FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane…Drug · Boehringer Ingelheim Roxane IncCGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.Class III
- Oct 21, 2015FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane…Drug · Boehringer Ingelheim Roxane IncCGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.Class III
- Aug 5, 2015COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg…Drug · Boehringer Ingelheim Roxane IncDefective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.Class II
- Jun 3, 2015Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottle…Drug · Boehringer Ingelheim Roxane IncSubpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.Class II
- Aug 6, 2014OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onlyDrug · Boehringer Ingelheim Roxane IncFailed Stability Specifications: Out of specification result for preservative sodium benzoate.Class III
- Jul 16, 2014Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, IncDrug · Boehringer Ingelheim Roxane IncFailed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time pointClass II
- May 14, 2014Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, IncDrug · Boehringer Ingelheim Roxane IncLabeling: 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.Class III
- May 14, 2014Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, IncDrug · Boehringer Ingelheim Roxane IncLabeling: 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.Class III
- Apr 16, 2014Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsu…Drug · Boehringer Ingelheim Roxane IncDefective 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.Class III
- Dec 18, 2013Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in bliste…Drug · Boehringer Ingelheim Roxane IncSubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.Class III
- Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelhei…
- SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx…
- Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blis…
- Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelhei…
- Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed…
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