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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
cGMP deviations.
Lack of Assurance of Sterility
cGMP deviations.
cGMP deviations.
cGMP deviations.
cGMP deviations.
cGMP deviations.
Subpotent drug
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Presence of particulate matter
Presence of particulate matter
Failed Dissolution Specifications
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…