Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Superpotent Drug
Defective container: Out of specification for container integrity leading to bottles leaking.
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Failed Stability Specifications; out of specification for shear.
Defective container: possibility for lack of seal integrity.
Marketed without ANDA/NDA approval
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
This recall involves bottles of LifeSeasons Blood Nourish-R dietary supplement with iron. The brown, 60-capsule count bottles, have a white and red label, with the LifeSeasons logo printed on the front and the UPC code 853760002452 on the back. The following lot number and corresponding expiration date are printed on the underside of the bottle: Lot Numbers Expiration Dates 06242008 8/23 03262012 10/23 06242007 10/23 06242021 11/23