Class III · Low risk Ongoing
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Reason Cross Contamination with Other Products
Is Nebivolol recalled?
7 FDA recalls mention Nebivolol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nebivolol.
Class II · Moderate risk Ongoing
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road…
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk Terminated
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx…
Reason Failed Dissolution Specification; at the 6-month stability time point
Class II · Moderate risk Terminated
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc…
Reason Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Class II · Moderate risk Terminated
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from…
Reason Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification…
Class II · Moderate risk Terminated
NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456140530.
Reason Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC…
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock…
Reason Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
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