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CLOMIPRAMINE HYDROCHLORIDE
Wed Nov 12 2025
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Reason for Recall
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Manufacturers
| Drug | Manufacturer |
|---|---|
| CLOMIPRAMINE HYDROCHLORIDE | Northstar Rx LLC. |
Number of affected units
N/A
Distribution pattern
Distributed in one (1) State: TX.
UPCs
Info not provided.
Package NDCs
| NDC |
|---|
| 16714-849-02 |
| 16714-849-01 |
| 16714-849-03 |
| 16714-850-01 |
| 16714-850-03 |
| 16714-850-02 |
| 16714-851-01 |
| 16714-851-03 |
| 16714-851-02 |
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