Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
SUN PHARMACEUTICAL INDUSTRIES
Presence of Particulate matter: Particulate matter identified as glass.
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Class I - Dangerous
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Presence of foreign substance: identified as aluminum.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Cross Contamination
Cross Contamination
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class I - Dangerous
Failed Release Testing: Out of specification for particulate matter test.
Out of specification for assay
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Failed Dissolution Specifications: Out of specification for dissolution.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Dissolution Specifications
Subpotent: Out of Specification result observed for low assay
Out of Specification result observed in content uniformity testing
Presence of Foreign Substance: Metal embedded in a tablet.
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Subpotent drug
Class I - Dangerous
CGMP Deviations
Failed Dissolution Specifications; during stability testing
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Failed Content Uniformity Specifications
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Presence of foreign substance
Discoloration
Presence of Foreign Substance
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
cGMP - Water leakage
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Failed Moisture Limits
Failed Moisture Limits
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Subpotent and Presence of Particulates .
Presence of foreign substance: identified as activated carbon.
Microbial Contamination of Non-Sterile Product
Failed Moisture Limits: Out of specification for water content
Failed Impurities/Degradation Specifications
Subpotent
Failed Impurity/Degradation Specifications
Incorrect Labeling: Incorrect lot number on secondary packaging
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Class I - Dangerous
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class I - Dangerous
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.