Recalls of antihistamines, decongestants and nasal sprays.
314 recalls in this category, newest first.
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Failed Impurities/Degradation Specifications
Microbial Contamination of Non-Sterile Products
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Tablet/Capsules Imprinted with Wrong ID
Tablet/Capsules Imprinted with Wrong ID
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
CGMP Deviations
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Defective Delivery System: The dip tube is clogged causing the spray not to work.
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
CGMP Deviations: potential presence of Burkholderia cepacia complex
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Microbial Contamination of Non-Sterile Products
Microbial contamination of Non-Sterile Products
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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