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CARVEDILOL
Wed Aug 20 2025
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Reason for Recall
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Manufacturers
| Drug | Manufacturer |
|---|---|
| CARVEDILOL | Glenmark Pharmaceuticals Inc., USA |
Number of affected units
14,976 bottles
Distribution pattern
Nationwide within the USA
UPCs
Info not provided.
Package NDCs
| NDC |
|---|
| 68462-162-60 |
| 68462-162-01 |
| 68462-162-18 |
| 68462-162-05 |
| 68462-162-10 |
| 68462-163-60 |
| 68462-163-01 |
| 68462-163-18 |
| 68462-163-05 |
| 68462-163-10 |
| 68462-164-60 |
| 68462-164-01 |
| 68462-164-18 |
| 68462-164-05 |
| 68462-164-10 |
| 68462-165-60 |
| 68462-165-01 |
| 68462-165-18 |
| 68462-165-05 |
| 68462-165-10 |
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