Class III · Low risk Terminated
Rite Aid Pharmacy loratadine orally disintegrating tablets USP
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
QC Quality Choice Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Nisoldipine Extended Release Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Verapamil Hydrochloride Extended-Release tablets
Reason Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Class III · Low risk Terminated
Phentermine Hydrochloride Capsules
Reason Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk Terminated
Allopurinol Tablets
Reason Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-¿release Tablets USP
Reason Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Class III · Low risk Terminated
Imipramine HCl Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Imipramine HCl Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Imipramine HCl Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Felodipine Extended-Release Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Felodipine Extended-Release Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Felodipine Extended-Release Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Phentermine Hydrochloride Capsules
Reason Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk Terminated
Mometasone Furoate Ointment USP
Reason Subpotent drug
Class III · Low risk Terminated
Intermezzo
Reason Failed dissolution specifications
Class III · Low risk Terminated
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…
Reason Subpotent Drug: menthol and methyl salicylate below specification
Class III · Low risk Terminated
Cvs Sugar Free Black Cherry Cough Drops
Reason Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Class III · Low risk Terminated
Panadol
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
HydrOXYzine Hydrochloride Tablets
Reason Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class III · Low risk Terminated
Metoclopramide Oral Solution
Reason Defective Container: Lids on unit dose cups are not fully qualified.
Class III · Low risk Terminated
Desmopressin Acetate Tablets
Reason Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk Terminated
Desmopressin Acetate Tablets
Reason Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk Terminated
Cortisol-Mc
Reason Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
Class III · Low risk Terminated
Disulfiram tablets
Reason Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.