All recalls7,877 total
Product contains cyclamates.
Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6.
CGMP Deviations
CGMP Deviations
The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
Sprouts have the potential to be contaminated with Listeria monocytogenes
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Failed Dissolution Specifications
Foreign object (metal pieces).
Potential contamination with blue pieces of plastic
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Product tested positive for Salmonella
Firm received complaints of infant choking.
Undeclared Yellow #5
Firm received complaints of infant choking.
Lack of Assurance of Sterility
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Dissolution Specifications.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.