Page 39 of 40 · 1,986 total recalls
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
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...
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs),...
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Failed Dissolution Specifications
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients...
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
Subpotent drug; Clavulanate Potassium component
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil...
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency...
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency...
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with...
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Product contains undeclared cyclamates.
Product contains undeclared cyclamates.
Labeling: Not Elsewhere Classified
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