Class III · Low risk
Nebivolol Tablets
Cross Contamination with Other Products
Nebivolol HCL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD73611_1, EXP: 5/30/2014; RASAGILINE MESYLATE, Tablet, 0.5 mg, NDC 68546014256, Pedigree: W002929, EXP: 6/10/2014.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456140530.
Affected NDC
0456-1405-30
Compare with the code on your package — it is the most precise check available.
Drug: Nebivolol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bystolic nebivolol hydrochloride NDC 00456-1405 |
5 mg/1 | Tablet Oral |
Allergan, Inc. | Rx |
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-915-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nebivolol recalls
See all
Class II · Moderate risk
Nebivolol Tablets
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specification; at the 6-month stability time point
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
Other recalls by Aidapak Services, LLC
All 2013 recalls
Class II · Moderate risk
Methazolamide
Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014.
Class II · Moderate risk
Perphenazine
Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD21790_28, EXP: 5/1/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W002730, EXP: 6/6/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: W003680, EXP: 6/25/2014; VENLAFAXINE HCL
Class II · Moderate risk
Trifluoperazine HCL
Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree: AD52778_88, EXP: 5/21/2014.
Class II · Moderate risk
Cholecalciferol
Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014; QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24/2014; POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, NDC 00486111101, Pedigree: AD52778_34, EXP: 5/20/2
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