Fluphenazine HCl Elixir
Failed Stability Specifications
Class I — High risk. Reasonable probability of serious harm or death.
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX.
Drug: Alcohol
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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