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This recall to replace involves bottle caps for Temodar and Temozolomide (generic) capsules, an oral chemotherapy drug. The capsules were distributed in 5- and 14-count brown glass bottles that have white plastic child-resistant caps. A white label affixed to the bottle has the word "Temozolomide" printed in black lettering.
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Failed Stability Specifications: product may not meet specification limit for assay test.
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Subpotent Drug: Subpotent atorvastatin.
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.