Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Apotex
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
CGMP Deviations: potential presence of Burkholderia cepacia complex
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class I - Dangerous
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Failed Dissolution Specifications: Out of specification for dissolution.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class I - Dangerous
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Presence of foreign substance: glass particles
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I - Dangerous
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Superpotent Drug: Product may not meet specifications throughout shelf life.
CGMP Deviations
CGMP Deviations
Class I - Dangerous
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Failed Stability Specifications: product may not meet specification limit for assay test.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class I - Dangerous
Subpotent drug
Subpotent drug
Subpotent drug
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class I - Dangerous
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I - Dangerous
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.