Amerigen Pharmaceuticals Temozolomide capsules, 20 mg recall — FDA D-0249-2019
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Chrysler(FCA US LLC) is recalling certain 2019 Jeep Cherokee vehicles equipped with 2.4L engines. Improper transmission calibration may result in a stall.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at…
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.