Subpotent Drug: Out of specification for assay
AuroMedics Pharma
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Presence of Particulate Matter: Piece of metal found in a vial
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Discoloration and failed pH specifications
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class I - Dangerous
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I - Dangerous
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I - Dangerous
Discoloration; Hazy solution found in one vial instead of a clear solution.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Crystallization: Presence of visible particulate matter.
Crystallization: Presence of visible particulate matter.
Class I - Dangerous
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Presence of Foreign Substance: Foreign material found inside the vial.
Class I - Dangerous
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class I - Dangerous
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Crystallization: Presence of visible particulate matter.
Class I - Dangerous
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class I - Dangerous
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Presence of Particulate Matter: identified as glass and silicone material
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class I - Dangerous
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass