1,709 recalls · Class III, newest first
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Reason Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Reason Failed Dissolution Specifications
Reason Failed Impurities/ Degradation Specifications
Reason Failed Impurities/ Degradation Specifications
Reason Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Reason Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Reason Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
Reason Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Reason Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Reason Short Fill
Reason Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Reason Discoloration: product contains brown pellets
Reason Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Reason Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Reason Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Reason Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Reason Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Reason Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Reason Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Reason Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.