Boehringer Ingelheim Roxane Inc Recalls

All product recalls associated with Boehringer Ingelheim Roxane Inc.

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Recall Summary

Total Recalls

15

Past Year

0

Class I (Serious)

0

Most Recent

Sep 2015

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–15 of 15 recalls

Furosemide Tablets 20mg (Boehringer) – manufacturing deviation (2015)

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.

Class IIILow

FDASep 25, 2015Nationwide• Boehringer Ingelheim Roxane Inc

Furosemide Tablets 40mg (Boehringer) – manufacturing deviation (2015)

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.

Class IIILow

FDASep 25, 2015Nationwide• Boehringer Ingelheim Roxane Inc

Combivent Respimat (Boehringer Ingelheim) – defective delivery system (2015)

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

Class IIModerate

FDAJul 24, 2015Nationwide• Boehringer Ingelheim Roxane Inc

Acarbose Tablets (Boehringer) – Subpotent Drug (2015)

Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

Class IIModerate

FDAApr 2, 2015Nationwide• Boehringer Ingelheim Roxane Inc

Oxycodone Hydrochloride Oral Solution (Boehringer) – preservative failure (2014)

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

Class IIILow

FDAJul 28, 2014Nationwide• Boehringer Ingelheim Roxane Inc

Calcitriol Oral Solution (Boehringer Ingelheim) – Impurity Specification (2014)

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Class IIModerate

FDAMay 1, 2014Nationwide• Boehringer Ingelheim Roxane Inc

Mercaptopurine Tablets (Boehringer) – expiration date error (2014)

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.

Class IIILow

FDAApr 4, 2014Nationwide• Boehringer Ingelheim Roxane Inc

Azathioprine Tablets (Boehringer) – expiration date error (2014)

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.

Class IIILow

FDAApr 4, 2014Nationwide• Boehringer Ingelheim Roxane Inc

Spiriva HandiHaler (Boehringer) – Delivery System Issue (2014)

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.

Class IIILow

FDAMar 27, 2014Nationwide• Boehringer Ingelheim Roxane Inc

SPIRIVA HandiHaler (Boehringer) – Foreign Particle Risk (2013)

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

Class IIILow

FDAAug 30, 2013Nationwide• Boehringer Ingelheim Roxane Inc

Prednisone Tablet (Boehringer Ingelheim) – Missing Label (2013)

Labeling: Missing Label; missing label on blister card

Class IIILow

FDAJun 14, 2013Nationwide• Boehringer Ingelheim Roxane Inc

Oxcarbazepine Oral Suspension (Boehringer) – Resuspension Issue (2013)

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Class IIModerate

FDAApr 3, 2013Nationwide• Boehringer Ingelheim Roxane Inc

Oxcarbazepine Tablets (Boehringer Ingelheim) – Subpotent Drug (2013)

SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

Class IIILow

FDAMar 18, 2013Nationwide• Boehringer Ingelheim Roxane Inc