Pfizer Tikosyn (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle recall — FDA D-1253-2014
Presence of Foriegn Tablets/Capsules: A single Tikosyn (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn (dofetilide) 500 mcg (0.5 mg).
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10,690 detailed records are currently available in this category.
Presence of Foriegn Tablets/Capsules: A single Tikosyn (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn (dofetilide) 500 mcg (0.5 mg).
Subpotent Drug: Phenylephrine component is subpotent.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished…
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary…
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary…
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary…
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine…
Penicillin Cross Contamination
Penicillin Cross Contamination
Penicillin Cross Contamination
Penicillin Cross Contamination
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States,…
Penicillin Cross Contamination
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of…
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Penicillin Cross Contamination
Penicillin Cross Contamination
Penicillin Cross Contamination
Penicillin Cross Contamination
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