11,815 recalls · Class II, newest first
Reason Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA…
Reason Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Reason Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Reason Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Reason Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Reason Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from…
Reason Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from…
Reason Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Reason Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for…
Reason Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Reason Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a…
Reason Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Reason Presence of Foreign Substance: Presence of stainless steel particles.
Reason Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Reason Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Reason Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Reason Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were…
Reason Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Reason Subpotent Drug.