Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
National Drug Code
Is NDC 68462-0165-01 recalled?
Carvedilol · 100 TABLET, FILM COATED in 1 BOTTLE (68462-165-01)
Yes — this exact package was recalled
1 FDA recall names the code 68462-0165-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
4 of these recalls are still ongoing.
- Active ingredient
- Carvedilol
- Strength
- CARVEDILOL 25 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Type
- Human Prescription Drug
- Product code
- 68462-0165
Recalls naming this package
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
Class II · Moderate risk
Carvedilol Tablets USP 25 mg
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II · Moderate risk
Carvedilol Tablets
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 68462-0164 Carvedilol 5
- 68462-0248 See recall 4
- 68462-0357 Potassium Chloride 4
- 68462-0562 Diltiazem Hydrochloride 4
- 68462-0249 See recall 3
- 68462-0626 azelaic acid 3
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