Class II · Moderate risk
Levothroid
Subpotent; 9-month stability interval
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Thyro-Tab 0.075 mg.
Subpotent; 9-month stability interval
Class II · Moderate risk
Levothroid
Subpotent; 9-month stability interval
Class II · Moderate risk
Thyro-Tab 0.050 mg.
Subpotent; 9-month stability interval
Class II · Moderate risk
OFIRMEV (acetaminophen)
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Class II · Moderate risk
CMS-2374-R4 Custom US Breast Core Biopsy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
CMS-8934 Custom Phlebectomy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
Custom Access Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class II · Moderate risk
Synthroid (levothyroxine sodium)
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Class II · Moderate risk
Walgreens ASPIRIN FREE TENSION HEADACHE
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Class II · Moderate risk
CosMedix Serious Protection
Microbial Contamination of Non Sterile Product; mold
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate)
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Fentanyl Transdermal System
Subpotent; some patches may not contain fentanyl gel
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.300 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.137 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.125 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements