Class II · Moderate risk
S-Atropine 0.02% Opthalmic Solution
Lack of Assurance of Sterility
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
S-Atropine 0.01% Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
S-Ascorbic/Glutathione 1.25/1.25% Opth Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Ascorbic Acid 500mg/Ml Mdv Soln
Lack of Assurance of Sterility
Class II · Moderate risk
S-Amitriptyline 10mg/Ml Mdv Inj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Soothing Sore Relief
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk
Soothing Sore 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
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 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.