Failed Content Uniformity Specifications
AVKARE
Class I - Dangerous
Presence of a foreign substance.
Class I - Dangerous
Presence of a foreign substance.
Class I - Dangerous
Failed Impurity/Degradation Specifications
Class I - Dangerous
Failed Impurity/Degradation Specifications
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Class I - Dangerous
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class I - Dangerous
Out of Specification for Dissolution
Class I - Dangerous
LABELING: LABEL MIX-UP
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
LABELING: LABEL MIX-UP
Class I - Dangerous
Labeling: Label Mix-Up
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class I - Dangerous
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class I - Dangerous
Labeling: Label Mix-Up
Class I - Dangerous
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class I - Dangerous
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class I - Dangerous
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class I - Dangerous
Labeling: Label Error on Declared Strength
Class I - Dangerous
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class I - Dangerous
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class I - Dangerous
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class I - Dangerous
Failed Dissolution Specifications
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class I - Dangerous
Failed Stability Specifications.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class I - Dangerous
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class I - Dangerous
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Failed Dissolution Specifications
Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class I - Dangerous
Failed impurities/degradation specifications: Out of specification for a related compound C.
Class I - Dangerous
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug