Class II · Moderate risk Terminated
Haloperidol Decanoate Injection
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Terminated
Leucovorin Calcium for Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Acyclovir Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 26 mL Applicator
Reason Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class III · Low risk Terminated
Evrysdi
Reason Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Class III · Low risk Terminated
Asenapine Sublingual Tablets
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk Terminated
Asenapine Sublingual Tablets
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class II · Moderate risk Terminated
Estradiol Transdermal System Delivers 0.0375 mg/day
Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Class II · Moderate risk Terminated
Oxygen
Reason cGMP deviations
Class II · Moderate risk Terminated
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class III · Low risk Terminated
Dry Eye Test
Reason Subpotent Drug
Class II · Moderate risk Terminated
Betadine
Reason Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class II · Moderate risk Terminated
Itraconazole Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Riomet
Reason Microbial Contamination of Non-Sterile Product
Class I · High risk Terminated
Thumbs up 7 Red 70K capsules
Reason Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Terminated
Shogun-X capsules
Reason Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Terminated
Krazy Night capsule
Reason Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk Terminated
Lite'n Foamy Healthcare Personnel Handwash
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lite'n Foamy E2 Sanitizing Handwash
Reason CGMP Deviations
Class II · Moderate risk Terminated
Antiseptic Hand Cleaner
Reason CGMP Deviations
Class II · Moderate risk Terminated
foamyiQ Lemon Blossom Hand Sanitizer
Reason CGMP Deviations
Class I · High risk Terminated
Lite'n Foamy Lemon Blossom Hand Sanitizer
Reason Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Class III · Low risk Terminated
Lidocaine Ointment USP
Reason Failed Stability Specifications: product did not meet viscosity results.