Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package recall — FDA D-0385-2024
Failed Stability Specification: Water determination was found not complying with specification.
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Failed Stability Specification: Water determination was found not complying with specification.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
cGMP Deviations: Products were stored outside the drug label specifications.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Stability Specifications: Out of specification for blend uniformity.
Lack of Assurance of Sterility
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Failed Dissolution Specifications: Out of specification for dissolution.
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Lack of Assurance of Sterility
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Subpotent Drug: Out of specification for assay
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
CGMP Deviations: Potential Glass and Silicone particulates in product
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male…
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