Class II · Moderate risk
Carvedilol Tablets USP
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Carvedilol Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
Affected NDC
0378-3634-05
Compare with the code on your package — it is the most precise check available.
Drug: Carvedilol
- Recalling firm
- Viatris Inc
- NDC code
- 0378-3634-05
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0063-2023 · 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 Carvedilol recalls
See all
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Other recalls by Viatris Inc
All 2022 recalls
Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Cardura XL
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
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