Prescription Drugs

Sub-potent Drug; powder discoloration associated with decreased potency

Discoloration: Dotted and yellow spots on tablets

Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Discoloration: Dotted and yellow spots on tablets

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Subpotent drug

Out of specification for assay

Labeling: Wrong Barcode

Failed Dissolution Specifications

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

Lack of Assurance of Sterility: Complaints of syringe breakage

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Cross Contamination with Other Products

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Cross Contamination with Other Products