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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
This recall involves Mamisan Pain Relieving Topical Ointment jars. The ointment comes in an orange container with a white continuous thread lid and has the Mamisan trademark printed on top of the lid and on the label. The ointment was sold in a 3.52 ounce plastic jar. The wraparound label includes instructions and drug facts. Only jars with UPC code 860006498115 are included in the recall.
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of particulate matter: potential presence of metal particulates in the product.
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Presence of Foreign Tablets/Capsules
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Subpotent product:out of specification assay results observed during long term stability testing.
Subpotent product:out of specification assay results observed during long term stability testing.
Subpotent product:out of specification assay results observed during long term stability testing.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Incorrect Product Formulation
Cross Contamination with Other Products
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis