Class II · Moderate risk Terminated
Soothing Sore Relief
Reason Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Soothing Sore Relief
Reason Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk Terminated
Superior Pain & Itch Relief
Reason Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk Terminated
Superior Pain & Itch Relief
Reason Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk Terminated
Pre-Tat
Reason Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk Terminated
Pre-Tat
Reason Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class II · Moderate risk Terminated
Carbamazepine
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Vivitrol
Reason 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 Terminated
Clotrimazole and Betamethasone Dipropionate Cream USP
Reason Temperature Abuse: Complaints received of liquidy texture.
Class III · Low risk Terminated
Eptifibatide Injection
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk Terminated
Eptifibatide Injection
Reason 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 Terminated
Eptifibatide Injection
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class II · Moderate risk Terminated
Lisinopril/HCTZ 20mg/12.5mg Tablet
Reason 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 Terminated
Simvastatin Tablets
Reason Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class II · Moderate risk Terminated
Bexarotene Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Clear Eyes Redness Relief Hand Pocket Pal Tray Display
Reason 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 Terminated
Clear eyes REDNESS RELIEF
Reason 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 Terminated
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display
Reason 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 Terminated
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
Reason 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 Terminated
Clear Eyes Maximum Redness Relief Club Pack Display
Reason 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 Terminated
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
Reason 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 Terminated
Clear Eyes Redness Relief Club Pack Display
Reason 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 Terminated
Clear Eyes Assorted Sidekick Floor Stand Display
Reason 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 Terminated
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display
Reason 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 Terminated
Clear Eyes Assorted IRC Display
Reason 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.