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Labeling: Label Mix-Up
Subpotent Drug
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Nestle Health Science (NHS U.S., LLC) is initiating a recall of Douglas Labs Stress-B-Plus Dietary Supplement Tablets, 90 tablets per bottle. The bottle is white and made of plastic. Lot Numbers 50335944,50344396, expiration date 04/11/2026. The product is being recalled because of Incorrect formulation manufactured vs label claims. Product was manufactured with Niacin (as Nicotinic acid) and supplement facts panel states contains Niacin (as Niacinamide).
Failed Impurities/Degradation Specifications.
Defective Container: Firm received complaints of broken tube at the seal.
Presence of Particulate Matter: Presence of glass particulates.
cGMP violations