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cGMP deviations
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Chemical Contamination
Defective Container: broken or leaking bottles.
CGMP Deviations
Elevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
CGMP Deviations: Inconsistency in the water systems.
cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Defective Delivery System: The dip tube is clogged causing the spray not to work.
CGMP deviations
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria