Ingredients were not pasteurized after blending as required by State of Wisconsin.
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Ingredients were not pasteurized after blending as required by State of Wisconsin.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Ingredients were not pasteurized after blending as required by State of Wisconsin.
Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01
Wilshire Pharmaceuticals
Failed Dissolution Specifications
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Failed Dissolution Specifications
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
Wilshire Pharmaceuticals
Failed Dissolution Specifications
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.