Class II · Moderate risk Terminated
Maxim Instant Foam Hand Sanitizer
Reason CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
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Class III · Low risk Terminated
Nighttime Sleep-Aid
Reason Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III · Low risk Terminated
Acetaminophen 500 mg tablet
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk Terminated
Acetaminophen 325 mg tablets
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class II · Moderate risk Terminated
Acetaminophen Injection
Reason Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class III · Low risk Terminated
Zynrelef
Reason Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion 0.05%
Reason Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk Ongoing
PrednisoLONE Oral Solution USP
Reason Defective Container: Product has incomplete induction seals.
Class I · High risk Terminated
Banana Boat hair & scalp defense
Reason Chemical contamination: presence of benzene
Class II · Moderate risk Terminated
Rifampin Capsules
Reason CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk Terminated
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Divalproex Sodium Extended Release Tablets
Reason Failed dissolution specifications.
Class III · Low risk Terminated
Azacitidine for Injection
Reason Subpotent Drug
Class II · Moderate risk Terminated
fentaNYL Citrate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg*…
Reason Discoloration
Class III · Low risk Terminated
Azacitidine for Injection 100mg/vial Lyophilized Powder
Reason Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class I · High risk Terminated
SANGTER Energy Supplement Capsules
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Class I · High risk Terminated
Sustango
Reason Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class II · Moderate risk Terminated
Matzim LA
Reason Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk Terminated
Matzim LA
Reason Failed Dissolution Specifications: below specification limits for dissolution.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Labeling: Label Error on Declared Strength
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol
Reason Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol
Reason Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk Terminated
Prednisone Tablets USP
Reason Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets