Class I - Dangerous
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Aurobindo Pharma USA
Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Discoloration: Dotted and yellow spots on tablets
Discoloration: Dotted and yellow spots on tablets
Class I - Dangerous
Failed dissolution specifications - results obtained were below spec average.
cGMP deviations: Batch was released prior to approval.
cGMP deviations: Batch was released prior to approval.
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I - Dangerous
Subpotent Drug: Out of Specification results for Assay
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Superpotent and Failed Tablet/Capsule Specifications
Failed Impurities/Degradation Specifications
Class I - Dangerous
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Presence of Foreign Substance- Potential of metal contamination.
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Failed Impurities/ Degradation Specifications
Failed Impurities/ Degradation Specifications
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class I - Dangerous
Presence of Particulate Matter: One vial was found to contain a hair.
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class I - Dangerous
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label