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Chemical Contamination: presence of benzene
Presence of particulate matter: glass
Presence of Particulate Matter; identified as glass
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
CGMP Deviations: Stability data does not support expiry date.
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
FDA lab analysis of product sampled revealed Chromium content was determined subpotent as 16 mcg/serving or 16% of declared.
Failed Impurities/Degradation Specifications
Potential mold contamination
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.