💊 Drugs • 3,200 recalls
Linde Eckstein Gmbh + Co KG
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Linde Eckstein Gmbh + Co KG
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Fagron Compounding Services LLC
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Presence of Foreign Substance: possibility of the presence of metal in the product.
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
GMP Deviations; product may not meet cGMP requirements
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.