A G Specialty Foods keep refrigerated, net wt recall — FDA F-1304-2022
Potential contamination with Salmonella.
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Potential contamination with Salmonella.
Manufactured using organic strawberries potentially contaminated with Hep A.
Foreign material - plastic
Products were made with peanut butter contaminated with Salmonella.
Label declares Teriyaki Sauce but does not declare Wheat and Soy.
Potential contamination with Salmonella.
Foreign object (metal).
Potential Salmonella contamination.
Foreign object (metal).
Manufactured using organic strawberries potentially contaminated with Hep A.
Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 5.57.
Products were made with peanut butter contaminated with Salmonella.
Products were made with peanut butter contaminated with Salmonella.
The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
cGMP deviations
Lack of assurance of sterility
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain…
Lack of assurance of sterility
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Lack of assurance of sterility
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Lack of assurance of sterility
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