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Non-Sterility
An extraneous peak was observed for dissolution testing.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Out-of-specification organic impurity results obtained during routine stability testing.
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
This recall involves The Vitamin Shoppe's Vthrive Bioactive Women's One-Daily Multi vitamins. The 60-count capsules were sold in an amber bottle with a gray top. Vthrive and Bioactive Women's One-Daily Multi are printed on a blue label on the bottle. Item number VS-6104 can be found on the back of the bottle and lot number 006218, 006454, 006495 or 006779 on the bottle's underside. Only the 60-count bottles are included in this recall.
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Subpotent Drug
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.