Class II · Moderate risk Terminated
Urolet Mb Urinary Antiseptic
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Hyolev MB URINARY ANTISEPTIC Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Sodium Chloride Ophthalmic Solution
Reason Subpotent Drug: concentration of product is less than labeled amount.
Class III · Low risk Terminated
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Reason Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Class III · Low risk Terminated
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit
Reason Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Class II · Moderate risk Terminated
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles
Reason Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Class III · Low risk Terminated
Ceftriaxone for Injection
Reason Labeling: Missing Label
Class III · Low risk Terminated
Invokamet
Reason Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Class III · Low risk Terminated
HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx…
Reason Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).
Class III · Low risk Terminated
Zeasorb AF
Reason Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Class III · Low risk Terminated
Olanzapine tablets
Reason Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Class III · Low risk Terminated
AHP NIFEdipine Capsules
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial
Reason Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Class III · Low risk Terminated
Testosterone Cypionate 200 mg/mL in Sesame Oil
Reason Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Class II · Moderate risk Terminated
Succinylcholine Chloride
Reason Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Class III · Low risk Terminated
NIFEdipine Capsules USP
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
DIPYRIDAMOLE Tablets USP
Reason Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class II · Moderate risk Terminated
Persantine
Reason Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class II · Moderate risk Terminated
Travoprost Ophthalmic Solution USP
Reason Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Class II · Moderate risk Terminated
Phenobarbital Tablets
Reason Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Class II · Moderate risk Terminated
PredniSONE Tablets USP
Reason Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class III · Low risk Terminated
Paricalcitol Capsules
Reason Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Class II · Moderate risk Terminated
USCG Boat Response Kit - Product Code 80-0353
Reason Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.