REVITADERM WOUND CARE GEL recall — FDA D-0668-2022
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Super Potent and Failed Reconstitution Time
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Super Potent
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Sub Potent
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Sub Potent
Product found to be Sub Potent or Exceeded reconstitution time
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making…
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
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