Overview of recall records associated with Aurobindo Pharma USA Inc., including dates, categories and classifications where available.
Classification mix: Class II: 35, Class III: 4, Class I: 2.
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
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
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.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
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
Presence of Particulate Matter: One vial was found to contain a hair.
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.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
This page summarizes recall records in which the official source identifies Aurobindo Pharma USA Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
