11,818 recalls · Class II, newest first
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Presence of Foreign Substance: Presence of stainless steel particles.
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.