11 FDA recalls mention Dimethicone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dimethicone.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Reason Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found…
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Reason Microbial Contamination of a Non-Sterile Product.
Reason Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Reason CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Reason Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Reason Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
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