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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Lack of Assurance of Sterility: Potential for flexible container leaks.
Failed stability specifications: Out of specification for hardness test
Failed stability specifications: Out of specification for hardness test
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate…
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
Lack of Assurance of Sterility.
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Subpotent Drug
Failed Dissolution Specifications
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
Lack of Assurance of Sterility