Class II · Moderate risk
Soothing Sore Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
FDA Drug Recalls
1,586 recalls · Class II, newest first
Class II · Moderate risk
Superior Pain & Itch Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Superior Pain & Itch Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
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
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 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 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.
Class II · Moderate risk
Macrobid Urinary Tract Anitbacterial
Failed dissolution specifications
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Failed dissolution specifications