Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Ampicillin Capsules
Reason Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class III · Low risk Terminated
Methocarbamol Tablets
Reason Presence of Foreign Substance: Presence of hair.
Class III · Low risk Terminated
Topicort
Reason Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Class III · Low risk Terminated
Dexmethylphenidate HCl Extended-Release
Reason Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Class III · Low risk Terminated
Hydralazine Hydrochloride Injection
Reason Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class III · Low risk Terminated
Meijer Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Wal-itin Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Sunmark loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Up&Up loratadine orally disintegrating tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Safeway Care Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Premier Value Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Ohm Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Major loratadine orally disintegrating tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Leader Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
HEB Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Health Mart Pharmacy loratadine orally disintegrating tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Fred's Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Equaline Original Prescription Strength
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Discount Drug Mart Food Fair
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
CVS Pharmacy
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
CareOne Original Prescription Strength
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Health Best Choice Care
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.