Cyclobenzaprine HCl Tablets
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
11,818 recalls · Class II, newest first
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective container: Oral solution leaking from container.
Lack of Sterility Assurance
Lack of Sterility Assurance
Lack of Sterility Assurance
Lack of Sterility Assurance
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Presence of foreign substance: glass particle
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
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.
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.