18,003 recalls, newest first
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Failed Content Uniformity Specifications; at the 18 month time point.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Subpotent
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Discoloration; due to prolonged heat exposure.
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.