Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
PRE-TAT (lidocaine)
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Carbamazepine
Failed Dissolution Specifications
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Temperature Abuse: Complaints received of liquidy texture.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class II · Moderate risk
Lisinopril/HCTZ 20mg/12.5mg Tablet
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Class III · Low risk
Simvastatin Tablets
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class II · Moderate risk
Bexarotene Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Clear Eyes Redness Relief Hand Pocket Pal Tray Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Redness Relief Club Pack Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Redness Relief Club Pack Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Assorted Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Assorted IRC Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes MAXIMUM REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes MAXIMUM ITCHY EYE RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.